Panels › Hematology › Product code GJT · Class 2
Plasma, Coagulation Factor Deficient
Regulation 864.7290
0510(k)s in 12 months (79 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GJT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 1992 | K924394 | CLOTTING FACTOR V DEFICIENT PLASMA Behring Diagnostics, Inc. | GJT |
| May 11, 1992 | K915411 | DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA Baxter Diagnostics, Inc. | GJT |
| Sep 10, 1991 | K912679 | DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN) Baxter Healthcare Corp | GJT |
| Jun 15, 1990 | K902083 | CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE Helena Laboratories | GJT |
| May 25, 1990 | K901327 | ORTHO CORRECTION REAGENTS Ortho Diagnostic Systems, Inc. | GJT |
| Mar 6, 1990 | K900906 | FACTOR II DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900412 | FACTOR XII DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900411 | FACTOR XI DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900410 | FACTOR X DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900409 | FACTOR IX DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900408 | FACTOR VIII DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900407 | FACTOR VII DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Mar 6, 1990 | K900406 | FACTOR V DEFICIENT PLASMA Sigma Chemical Co. | GJT |
| Jan 25, 1990 | K900133 | FACTOR II DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Oct 6, 1989 | K895504 | ABNORMAL REFERENCE PLASMA-IX Medical Diagnostic Technologies, Inc. | GJT |
| Oct 6, 1989 | K895503 | ABNORMAL REFERENCE PLASMA-VIII Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893536 | FACTOR XI DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893535 | FACTOR VII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893534 | FACTOR XII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893533 | FACTOR V DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893525 | FACTOR VIII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893524 | FACTOR IX DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893523 | FACTOR X DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Nov 1, 1988 | K883692 | ORTHO FACTOR VII DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. | GJT |
| Nov 1, 1988 | K883691 | ORTHO FACTOR XI DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. | GJT |
| Nov 1, 1988 | K883690 | ORTHO FACTOR X DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. | GJT |
| Nov 1, 1988 | K883688 | ORTHO FACTOR XII DEFICIENT PLASMA Ortho Diagnostic Systems, Inc. | GJT |
| Mar 17, 1988 | K880874 | IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN Baxter Healthcare Corp | GJT |
| Feb 19, 1988 | K880292 | FACTOR VIII REFERENCE PLASMA Helena Laboratories | GJT |
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