Company ยท US
Emd Chemicals, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2004. Name variants (Inc, Corp, punctuation) are merged.
62510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 5 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 4 |
| JIS | Calibrator, Primary | 4 |
| CFR | Hexokinase, Glucose | 3 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 |
| DNN | Calibrators, Ethyl Alcohol | 3 |
| JIT | Calibrator, Secondary | 3 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 3 |
| LFR | Glucose Dehydrogenase, Glucose | 3 |
| CDO | Acid, Uric, Uricase (U.V.) | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 |
| GMQ | Antigens, Nontreponemal, All | 2 |
| IAF | Wright'S Stain | 2 |
| J | 2 | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| KQC | Stains, Hematology | 2 |
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 23, 2004 | K031367 | DUOPATH VEROTOXINS GLISA TEST Emd Chemicals, Inc. | GNA |
| Mar 31, 1999 | K990516 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS Emd Chemicals, Inc. | DNN |
| Jul 22, 1998 | K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS Emd Chemicals, Inc. | DLJ |
| Oct 1, 1997 | K973054 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS Emd Chemicals, Inc. | DNN |
| Dec 11, 1995 | K951494 | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) Emd Chemicals, Inc. | CIJ |
| Sep 6, 1995 | K951750 | GLUCOSE TEST ITEM NUMBER 97375/94 Emd Chemicals, Inc. | LFR |
| Jun 14, 1995 | K950234 | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 Emd Chemicals, Inc. | CEK |
| May 15, 1995 | K950128 | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 Emd Chemicals, Inc. | CEK |
| Dec 7, 1994 | K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 Emd Chemicals, Inc. | CEO |
| Dec 2, 1994 | K945368 | PHOSPHORUS TEST (PHOS) Emd Chemicals, Inc. | CEO |
| May 16, 1984 | K840883 | UNIPAK 100 ANALYZER, 65156 & CHEMISTR Emd Chemicals, Inc. | JJE |
| Mar 5, 1984 | K840477 | UNITIZED HEMATOLOGY SET 65132/93 Emd Chemicals, Inc. | GIF |
| Jan 24, 1984 | K834294 | ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB Emd Chemicals, Inc. | LCP |
| Dec 22, 1983 | K833448 | EPOS CHEMISTRY ANALYZER 5060 & 6410 Emd Chemicals, Inc. | JJE |
| Nov 3, 1983 | K833017 | SERUM IRON & TIBC#65084 & 65085 Emd Chemicals, Inc. | JIY |
| Sep 12, 1983 | K832480 | TRUST RPR TITRATION CARD TEST #65145 Emd Chemicals, Inc. | GMQ |
| Sep 12, 1983 | K832479 | TRUST RPR CARD TEST #65144 Emd Chemicals, Inc. | GMQ |
| May 16, 1983 | K831027 | EXTRELUT QE EXTRACTION COLUMNS Emd Chemicals, Inc. | KEA |
| May 9, 1983 | K831200 | IMMUNOHEMATOLOGICAL SALINE #97139 Emd Chemicals, Inc. | JCE |
| Apr 18, 1983 | K830832 | RHEUMATOID FACTOR-RAPID CARD TEST #65114 Emd Chemicals, Inc. | DHR |
| Apr 5, 1983 | K830241 | ULTRA CHEM BUN-UV #65080-65081 Emd Chemicals, Inc. | CDQ |
| Apr 5, 1983 | K830239 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA Emd Chemicals, Inc. | CHH |
| Feb 28, 1983 | K830309 | ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE Emd Chemicals, Inc. | CHH |
| Feb 28, 1983 | K830308 | ULTRA ZYME PLUS GAMMA GT #65055 & 56 Emd Chemicals, Inc. | JQB |
| Feb 18, 1983 | K830240 | ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 Emd Chemicals, Inc. | JQB |
| Feb 18, 1983 | K830238 | ULTRA CHEM CRESOLCAVERSACHEM #65082 Emd Chemicals, Inc. | CIC |
| Jan 28, 1983 | K823883 | ULTRAZYME PLUS GAMMA-GT, #64959/65032 Emd Chemicals, Inc. | JQB |
| Jan 9, 1983 | K823300 | BUN-UN CENTRIFICHUM 500, #65080/81 Emd Chemicals, Inc. | CDQ |
| Dec 28, 1982 | K823472 | ULTRA CHEM BAN-UV #65080 & 65081 Emd Chemicals, Inc. | CDQ |
| Dec 26, 1982 | K823402 | ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& Emd Chemicals, Inc. | CDQ |
| Dec 22, 1982 | K823354 | ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE Emd Chemicals, Inc. | CHH |
| Nov 5, 1982 | K822937 | GLUCOSE/UREA NITROGEN STANDARD Emd Chemicals, Inc. | JIX |
| Oct 27, 1982 | K822982 | MIDAS 100 HEMACOLOR STAIN #66030 Emd Chemicals, Inc. | HYB |
| Oct 27, 1982 | K822981 | MIDAS 1000 WRIGHT GIEMSA STAIN #66020 Emd Chemicals, Inc. | IAF |
| Oct 27, 1982 | K822980 | MIDAS 1000 WRIGHT STAIN #66010 Emd Chemicals, Inc. | IAF |
| Sep 17, 1982 | K822477 | CREATININE STANDARD #65072 Emd Chemicals, Inc. | JIS |
| Sep 17, 1982 | K822473 | CALCIUM STANDARD, ITEM #65075 Emd Chemicals, Inc. | JIS |
| Sep 14, 1982 | K822479 | BILIRUBIN CALIBRATOR #65071 Emd Chemicals, Inc. | JIT |
| Sep 14, 1982 | K822478 | ALBUMIN STANDARD, #65070 Emd Chemicals, Inc. | JIT |
| Sep 14, 1982 | K822476 | PHOSPHOROUS STANDARD #65073 Emd Chemicals, Inc. | JIS |
| Sep 14, 1982 | K822475 | TOTAL PROTEIN STANDARD, #65074 Emd Chemicals, Inc. | JIT |
| Sep 14, 1982 | K822474 | CHOLESTEROL STANDARD #65077 Emd Chemicals, Inc. | JIS |
| Sep 14, 1982 | K822418 | ULTRACHEM ENZYMATIC CHOL. OXIDASE Emd Chemicals, Inc. | CHH |
| Jun 25, 1982 | K821475 | ULTRACHEM E-GLU #64976&65040 Emd Chemicals, Inc. | CFR |
| Jun 3, 1982 | K821474 | ULTRACHEM URIC ACID AIDH #65047 Emd Chemicals, Inc. | CDO |
| Jun 3, 1982 | K821473 | ULTRAZYME PLUS CKI, #64978,65027&65028 Emd Chemicals, Inc. | CGS |
| Jun 3, 1982 | K821472 | ULTRACHEM CREA #64972 Emd Chemicals, Inc. | |
| Jun 2, 1982 | K821471 | ULTRAZYME PLUS ALP #64962,65029&65030 Emd Chemicals, Inc. | CJE |
| Jun 2, 1982 | K821470 | ULTRACHEM E-GLU #64976 & 65040 Emd Chemicals, Inc. | CFR |
| Jun 2, 1982 | K821469 | ULTRACHEM GLUC-DH, #65048 Emd Chemicals, Inc. | LFR |
Newest 50 of 62.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2011 | EMD Chemicals Inc. Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342
Made in India.
The product is a Class I, IVD dye and chemical stain f Terminated |
KQC | None listed |
| Sep 20, 2008 | EMD Chemicals Inc Histochemical PAS (Periodic Acid Schiff) Reaction Set'
Class I, IVD;
Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Perio Terminated |
HZT | None listed |
| Sep 16, 2008 | EMD Chemicals Inc EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml;
1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic. Terminated |
DNN | K990516 |
| Nov 3, 2007 | EMD Chemicals Inc Harleco
May and Grunwald's Stain;
0.17% w/v;
Methanol Solution UN1230;
EMD Chemicals Inc.
An Affilifate of Merck KGaA
Damstadt, Germany;
480 South Democrat Road;
Gibbstown, NJ 08027;
1 liter and 4 lit Terminated |
KQC | None listed |
| Feb 17, 2007 | EMD Chemicals Inc Anaerotest;Microbiology ,
50 test strips
1.15112
Store dry and tightly closed.
Store at + 15 C to +25C
Merck IVD
64271 Darmstadt, Germany Terminated |
J | None listed |
| Feb 17, 2007 | EMD Chemicals Inc Anaerotest for microbiology
Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes
Merck KgaA
64271 Darmstadt, Germany
1.19034.0002 17.08.06 1 unit
UPC 4 02 Terminated |
J | None listed |
| Dec 27, 2006 | EMD Chemicals Inc Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Terminated |
KKS | None listed |
| Mar 26, 2003 | EMD Chemicals Inc Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86. Terminated |
HZJ | None listed |
| Mar 26, 2003 | EMD Chemicals Inc Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item Number 68988/95 Terminated |
LCH | K990516 |
| Mar 26, 2003 | EMD Chemicals Inc Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Terminated |
LCH | K990516 |