Company ยท US
Reagents Applications, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1998. Name variants (Inc, Corp, punctuation) are merged.
63510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 4 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| JFJ | Catalytic Methods, Amylase | 2 |
| JGJ | Photometric Method, Magnesium | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 1998 | K982056 | RAICHEM CO2 REAGENT Reagents Applications, Inc. | KHS |
| Sep 24, 1997 | K972853 | CHOLESTEROL RAPID LIQUID REAGENT Reagents Applications, Inc. | CHH |
| Jul 30, 1992 | K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II Reagents Applications, Inc. | JJX |
| Dec 18, 1991 | K915191 | RAI-TROL ELEVATED LIPIDS CONTROL Reagents Applications, Inc. | JJY |
| Sep 25, 1991 | K913398 | RAICHEM(TM) CREATINE KINASE-MB REAGENT Reagents Applications, Inc. | CGS |
| May 9, 1991 | K911900 | RAICHEM SPIA C3 REAGENT Reagents Applications, Inc. | CZW |
| May 9, 1991 | K911899 | RAICHEM SPIA C4 REAGENT Reagents Applications, Inc. | DBI |
| May 8, 1991 | K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT Reagents Applications, Inc. | DAD |
| Dec 20, 1990 | K905085 | RAICHEM GGT REAGENT Reagents Applications, Inc. | JQB |
| Dec 20, 1990 | K905084 | RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV Reagents Applications, Inc. | CGS |
| Nov 13, 1990 | K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT Reagents Applications, Inc. | LKL |
| Sep 14, 1990 | K903123 | RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT Reagents Applications, Inc. | JIQ |
| Jun 28, 1990 | K902593 | RAICHEM(TM) SPIA(TM) CRP REAGENT Reagents Applications, Inc. | DCN |
| Mar 6, 1990 | K900875 | RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT Reagents Applications, Inc. | DDG |
| Feb 16, 1990 | K896845 | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT Reagents Applications, Inc. | CDL |
| Jan 25, 1990 | K896922 | RAICHEM TM HEMOGLOBIN REAGENT Reagents Applications, Inc. | GKK |
| Jan 25, 1990 | K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR Reagents Applications, Inc. | KRZ |
| Aug 2, 1989 | K894418 | RAICHEM(TM) SPIA(TM) IGA REAGENTS Reagents Applications, Inc. | CZP |
| Aug 2, 1989 | K894417 | RAICHEM(TM) SPIA(TM) IGM REAGENTS Reagents Applications, Inc. | DFT |
| Aug 1, 1989 | K894416 | RAICHEM(TM) SPIA(TM) IGG REAGENTS Reagents Applications, Inc. | KTO |
| Dec 14, 1988 | K883389 | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD Reagents Applications, Inc. | JIW |
| Aug 29, 1988 | K882726 | RAICHEM(TM) BILIRUBIN STANDARD Reagents Applications, Inc. | JIS |
| Jun 10, 1988 | K880576 | RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) Reagents Applications, Inc. | CJY |
| May 27, 1988 | K880880 | RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC Reagents Applications, Inc. | JGJ |
| Jan 21, 1988 | K874822 | RAICHEM(TM) MAGNESIUM REAGENT Reagents Applications, Inc. | JGJ |
| Jan 11, 1988 | K874382 | RAICHEM(TM) ALCOHOL REAGENT Reagents Applications, Inc. | DML |
| Jun 15, 1987 | K872080 | RAICHEM(TM) SPIA(TM) APO B REAGENTS Reagents Applications, Inc. | DFC |
| Jun 15, 1987 | K872079 | RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS Reagents Applications, Inc. | MSJ |
| Mar 13, 1987 | K870776 | RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT Reagents Applications, Inc. | CEO |
| Feb 12, 1987 | K864992 | RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) Reagents Applications, Inc. | JFY |
| Feb 12, 1987 | K864819 | RAICHEM (TM)SERUM IRON AND TIBC REAGENTS Reagents Applications, Inc. | JIY |
| Jan 5, 1987 | K864706 | RAICHEM(TM) AMMONIA REAGENT Reagents Applications, Inc. | JIF |
| Sep 26, 1986 | K863620 | RAICHEM(TM) CHLORIDE REAGENT Reagents Applications, Inc. | CHJ |
| Jun 27, 1986 | K862168 | RAICHEM CHOLINESTERASE REAGENT Reagents Applications, Inc. | DIH |
| May 29, 1986 | K861718 | AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109 Reagents Applications, Inc. | JFJ |
| May 29, 1986 | K861269 | RAICHEM AMYLASE REAGENT Reagents Applications, Inc. | JFJ |
| Dec 13, 1985 | K854544 | RAICHEM CO2 REAGENT Reagents Applications, Inc. | KHS |
| Nov 26, 1985 | K854540 | RAICHEM/K.E Reagents Applications, Inc. | JJQ |
| Jan 3, 1985 | K844316 | RAICHEM PHOSPHORUS REAGENT Reagents Applications, Inc. | CEO |
| Oct 31, 1984 | K843774 | RAICHEM X-HBDH REAGENT Reagents Applications, Inc. | JMK |
| Sep 20, 1984 | K843353 | RAICHEM CALCIUM REAGENT Reagents Applications, Inc. | CIC |
| Jul 9, 1984 | K842029 | TRIGLYCERIDES-GPO REAGENT Reagents Applications, Inc. | CDT |
| Jun 7, 1984 | K841892 | RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT Reagents Applications, Inc. | CIG |
| May 16, 1984 | K841466 | TOTAL PROTEIN REAGENT BIURET Reagents Applications, Inc. | CEK |
| Apr 18, 1984 | K840872 | RAICHEM CREATININE REAGENT Reagents Applications, Inc. | CGX |
| Sep 12, 1983 | K832463 | RAICHEM ALKALINE PHOSPHATASE REAGENT Reagents Applications, Inc. | CJE |
| Aug 26, 1983 | K831834 | RAICHEM ACID PHASPHATASE REAGENT Reagents Applications, Inc. | CKB |
| Jun 16, 1983 | K831585 | ALBUMIN REAGENT (BCG Reagents Applications, Inc. | CIX |
| Jun 16, 1983 | K831419 | RAICHEM LDH-P REAGENT W/SEPARATE START- Reagents Applications, Inc. | CFJ |
| Mar 21, 1983 | K830207 | RAICHEM HDL-CHOLESTEROL REAGENT Reagents Applications, Inc. | LBR |
Newest 50 of 63.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||