Panels › Clinical Chemistry › Product code JIS · Class 2
Calibrator, Primary
Regulation 862.1150
0510(k)s in 12 months (130 all time)
0recalls in 12 months (21 all time)
15recalls that name a 510(k)
Top companies in JIS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 1982 | K821813 | BECKMAN URIC ACID STANDARD Beckman Instruments, Inc. | JIS |
| May 3, 1982 | K821061 | ACE ALBUMIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Apr 1, 1982 | K820698 | SYVA ADVANCE STANDARDIZATION KIT 01 Syva Co. | JIS |
| Dec 31, 1981 | K813505 | FLAME PHOTOMETER CALIBRATION STANDARDS Fisher Scientific Co., LLC | JIS |
| Dec 31, 1981 | K813447 | SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR Rna Medical Corp. | JIS |
| Dec 22, 1981 | K813478 | TRIGLYCERIDE CALIBRATORS Gilford Diagnostics | JIS |
| Oct 23, 1981 | K812861 | CHOLESTEROL CALIBRATORS Gilford Diagnostics | JIS |
| Apr 17, 1981 | K810963 | BIO SET TM SUBSTRATE CALIBRATORS Boehringer Mannheim Corp. | JIS |
| Apr 14, 1981 | K810867 | FOLLICLE STIMULATING HORMONE (FSH) Pcl-Ria, Inc. | JIS |
| Mar 31, 1981 | K810743 | LECITHIN-SPINGOMYELIN STAND. & KITS Supelco, Inc. | JIS |
| Mar 31, 1981 | K810742 | AQUEOUS TRIOLEIN STANDARDS & KITS Supelco, Inc. | JIS |
| Mar 31, 1981 | K810618 | AMPULED FLAME PHOTOMETER STANDARDS United Diagnostics, Inc. | JIS |
| Mar 24, 1981 | K810587 | EMIT-TFG PRISMA THYROXINE CALIBRATORS Syva Co. | JIS |
| Feb 2, 1981 | K810092 | CHOLESTEROL STANDARD Anco Medical Reagents & Assoc. | JIS |
| Jan 26, 1981 | K810091 | GLUCOSE STANDARD Anco Medical Reagents & Assoc. | JIS |
| Dec 11, 1980 | K802631 | CREATININE STANDARDS Gilford Diagnostics | JIS |
| Sep 26, 1980 | K801501 | UV URIC ACID STANDARDS The Dow Chemical Co. | JIS |
| Aug 20, 1980 | K801665 | SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) Miles Laboratories, Inc. | JIS |
| Jun 30, 1980 | K801287 | EMIT AAII THYROXINE CALIBRATORS Syva Co. | JIS |
| Apr 4, 1980 | K800588 | NSI CALIBRATOR SET Nobel Scientific Industries, Inc. | JIS |
| Mar 3, 1980 | K800206 | ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. E.I. Dupont DE Nemours & Co., Inc. | JIS |
| Feb 11, 1980 | K800062 | PIPET CALIBRATION KIT Streck Laboratories, Inc. | JIS |
| Jan 21, 1980 | K800042 | LITHIUM STANDARD (1MM/L) Gilford Diagnostics | JIS |
| Oct 30, 1979 | K792046 | URIC ACID STANDARD Gilford Diagnostics | JIS |
| Aug 16, 1979 | K791315 | SPECTRO-SUR SET Helena Laboratories | JIS |
| Dec 4, 1978 | K781853 | CHOLESTEROL STANDARDS Bd Becton Dickinson Vacutainer Systems Preanalytic | JIS |
| Apr 24, 1978 | K780467 | EMIT ANTIEPILEPTIC DRUG CALIBRATORS Syva Co. | JIS |
| Nov 11, 1977 | K772025 | URIC ACID STD. FOR QUANT. URIC ACID Worthington Biochemical Corp. | JIS |
| Jan 26, 1977 | K770072 | BIO TROL-T TRIOLEIN SOLUTIONS Boehringer Mannheim Corp. | JIS |
| Oct 21, 1976 | K760806 | REFEREE AQUEOUS TRIGLYCERIDE STND Analytical Products, Inc. | JIS |
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