Company ยท US
Sclavo, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1992. Name variants (Inc, Corp, punctuation) are merged.
82510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 4 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 |
| DIH | Colorimetry, Cholinesterase | 3 |
| JFJ | Catalytic Methods, Amylase | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 |
| CIC | Cresolphthalein Complexone, Calcium | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 2 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 1992 | K914789 | ELISA CMV IGM Sclavo, Inc. | LKQ |
| Jan 23, 1992 | K914852 | ELISA TOXO IGM Sclavo, Inc. | LGD |
| Dec 27, 1991 | K914420 | ELISA RUBELLA IGM Sclavo, Inc. | LFX |
| Dec 27, 1989 | K895943 | NORMAL AND ABNORMAL CONTROL SERA Sclavo, Inc. | JJY |
| Nov 14, 1989 | K895822 | TOTAL BILIRUBIN L.F. Sclavo, Inc. | CIG |
| Oct 30, 1989 | K895847 | CREATININE 340 (ENZYMATIC) Sclavo, Inc. | CGX |
| Jan 27, 1989 | K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE Sclavo, Inc. | DIH |
| Jan 27, 1989 | K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE Sclavo, Inc. | DIH |
| Jan 27, 1989 | K873496 | ATYPICAL CHOLINESTERASE Sclavo, Inc. | DIH |
| Dec 29, 1988 | K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER Sclavo, Inc. | JJE |
| Dec 14, 1988 | K884649 | TOTAL IRON BINDING CAPACITY TEST Sclavo, Inc. | JQE |
| Aug 25, 1988 | K882325 | UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Sclavo, Inc. | GFO |
| Jul 21, 1988 | K881381 | REAGENTS FOR TSH ASSAY Sclavo, Inc. | JLW |
| May 27, 1988 | K881214 | IMMPULSE T, ASSAY REAGENTS Sclavo, Inc. | CDP |
| Apr 28, 1988 | K881204 | ACP KINETIC TEST (ACID PHOSPHATASE TEST) Sclavo, Inc. | CKB |
| Apr 28, 1988 | K881202 | IRON TEST Sclavo, Inc. | JIY |
| Feb 25, 1988 | K880016 | MODIFIED CRP LATEX TEST Sclavo, Inc. | DCK |
| Feb 19, 1988 | K874748 | IMMPULSE DIGOXIN ASSAY REAGENTS Sclavo, Inc. | LCS |
| Feb 11, 1988 | K875081 | IMMPULSE T4 ASSAY REAGENTS Sclavo, Inc. | CDX |
| Dec 14, 1987 | K873297 | DIFFERENTIAL I.M. SCREENING TEST Sclavo, Inc. | KTN |
| Nov 27, 1987 | K873782 | REUMA TEST Sclavo, Inc. | DHR |
| Oct 20, 1987 | K870516 | ALBUMIN SCREEN TEST Sclavo, Inc. | JIQ |
| Oct 6, 1987 | K873133 | BNP-AMYLASE TEST Sclavo, Inc. | JFJ |
| Sep 16, 1987 | K873134 | UNIFAST CK-MB Sclavo, Inc. | CGS |
| Sep 14, 1987 | K870268 | DIAGNOSTIC KIT FREE T3 AND FREE T4 Sclavo, Inc. | CEC |
| Sep 4, 1987 | K873135 | UNIFAST GAMMA-GT Sclavo, Inc. | JQB |
| Aug 27, 1987 | K872537 | PROTHROMBIN TIME TEST Sclavo, Inc. | GJS |
| Jul 7, 1987 | K872030 | UNI-FAST LACTATE DEHYDROGENASE (LDH-L) Sclavo, Inc. | CFJ |
| Jun 17, 1987 | K872029 | UNI-FAST CREATINE KINASE TEST (CK) Sclavo, Inc. | JHS |
| Apr 29, 1987 | K870629 | CALCIUM TEST Sclavo, Inc. | CIC |
| Apr 22, 1987 | K870630 | CHLORIDE TEST Sclavo, Inc. | CHJ |
| Mar 13, 1987 | K870632 | FAST URIC ACID Sclavo, Inc. | KNK |
| Mar 13, 1987 | K870631 | FAST GLUCOSE Sclavo, Inc. | CGA |
| Feb 6, 1987 | K865000 | IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS Sclavo, Inc. | LET |
| Feb 4, 1987 | K864661 | UNIFAST CALCIUM TEST Sclavo, Inc. | CIC |
| Jan 13, 1987 | K865102 | IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS Sclavo, Inc. | LES |
| Dec 22, 1986 | K864409 | IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS Sclavo, Inc. | LER |
| Dec 3, 1986 | K863327 | IMMPULSE IGE ASSAY REAGENTS Sclavo, Inc. | DGP |
| Sep 29, 1986 | K863486 | POTASSIUM TEST Sclavo, Inc. | CEJ |
| Jul 16, 1986 | K862554 | IMMPULSE PHENYTOIN ASSAY REAGENT Sclavo, Inc. | LGR |
| Jul 16, 1986 | K862528 | IMMPULSE PHENOBARBITAL ASSAY REAGENTS Sclavo, Inc. | LGQ |
| Jul 16, 1986 | K862507 | FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) Sclavo, Inc. | CHH |
| Jun 19, 1986 | K862014 | IMMPULSE FERRITIN ASSAY REAGENT Sclavo, Inc. | DBF |
| Apr 28, 1986 | K860900 | IMMPULSE FREE ESTRIOL ASSAY REAGENTS Sclavo, Inc. | CGI |
| Apr 7, 1986 | K860665 | ALPHA-AMYLASE TEST Sclavo, Inc. | JFJ |
| Jan 22, 1986 | K854783 | TRIGLYCERIDE'S TEST (TRIGLI-CINET) Sclavo, Inc. | CDT |
| Mar 29, 1985 | K850210 | ISOENZYME TEST LD-1 Sclavo, Inc. | CFE |
| Mar 5, 1985 | K850213 | ISOCONTROL SERUM CK-MB Sclavo, Inc. | JJT |
| Feb 7, 1985 | K850212 | ISOENZYME TEST CK-MB Sclavo, Inc. | CGS |
| Feb 7, 1985 | K850211 | ISOCONTROL SERUM LD- Sclavo, Inc. | JJT |
Newest 50 of 82.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||