Panels › Clinical Chemistry › Product code JJT · Class 1
Enzyme Controls (Assayed And Unassayed)
Regulation 862.1660
0510(k)s in 12 months (97 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in JJT
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Instruments, Inc. | 7 | 0 |
| Bio-Rad | 6 | 0 |
| Cala Diagnostics | 6 | 0 |
| Dade, Baxter Travenol Diagnostics, Inc. | 4 | 0 |
| Helena Laboratories | 4 | 0 |
| Clinical Controls, Inc. | 3 | 0 |
| Medical Analysis Systems, Inc. | 3 | 0 |
| Nyegaard & Co. A/S | 3 | 0 |
| Quantimetrix Corp. | 3 | 0 |
| Specialized Assays, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 2, 1988 | K874302 | QUANTIMETRIX TOTAL CREATINE KINASE CONTROL Quantimetrix Medical Industries | JJT |
| Nov 4, 1987 | K874141 | TITAN GEL REP CPK/LDH ISOENZYME CONTROL Helena Laboratories | JJT |
| Sep 14, 1987 | K872646 | VIRON(TM) bioMerieux, Inc. | JJT |
| Apr 13, 1987 | K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL U. S. Diagnostics, Inc. | JJT |
| Apr 13, 1987 | K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL U. S. Diagnostics, Inc. | JJT |
| Jun 13, 1986 | K861506 | DOCUMENT ENZYME LINEARITY TEST SETS Casco Standards | JJT |
| May 23, 1986 | K861512 | EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 Em Diagnostic Systems, Inc. | JJT |
| Apr 30, 1986 | K861329 | ISOTRAK AMYLASE ISOENZYME CONTROL SET Behring Diagnostics, Inc. | JJT |
| Apr 7, 1986 | K860764 | EMDS ENZYME VERIFIER, LEVELS I & II Em Diagnostic Systems, Inc. | JJT |
| Jan 17, 1986 | K855006 | CANTROL CK/MB CONTROL Canyon Diagnostics, Inc. | JJT |
| Jan 13, 1986 | K854973 | V-TREND OC CPK V-Tech, Inc. | JJT |
| Aug 23, 1985 | K853373 | DELTA TROL I & II Electro-Nucleonics Laboratories, Inc. | JJT |
| Jun 25, 1985 | K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) Seragen Diagnostics, Inc. | JJT |
| Jun 25, 1985 | K850907 | CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ Cala Diagnostics | JJT |
| Mar 5, 1985 | K850213 | ISOCONTROL SERUM CK-MB Sclavo, Inc. | JJT |
| Feb 7, 1985 | K850211 | ISOCONTROL SERUM LD- Sclavo, Inc. | JJT |
| Sep 13, 1984 | K843266 | ID ZONE NORMAL LD ISOENZYME CONTROL Beckman Instruments, Inc. | JJT |
| Sep 13, 1984 | K843265 | ID ZINE LD ISOENZYME CONTROL ABNORM Beckman Instruments, Inc. | JJT |
| Apr 13, 1984 | K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM Seragen Diagnostics, Inc. | JJT |
| Nov 10, 1982 | K822984 | ID-ZONE LD ISOENZYME CONTROL Beckman Instruments, Inc. | JJT |
| Sep 30, 1982 | K822646 | QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM Beckman Instruments, Inc. | JJT |
| Jul 22, 1982 | K821981 | TITAN GEL CPK/LDH ISOENZYME CONTROL Helena Laboratories | JJT |
| May 14, 1982 | K821183 | TARGET ISOCHECK CONTROL SERUM Smithkline Diagnostics, Inc. | JJT |
| Mar 4, 1982 | K820360 | AALTO LDH ISOENZYME CONTROL SERUM Aalto Scientific, Ltd. | JJT |
| Oct 2, 1981 | K812671 | EMBRITROL CK-MB CONTROLS Intl. Immunoassay Laboratories, Inc. | JJT |
| Apr 14, 1981 | K810870 | GEMENI CK-MB ISOENZYME ABNORMAL SERUM Gemini, Inc. | JJT |
| Mar 31, 1981 | K810725 | QUALITROL #65057 Harleco | JJT |
| Jan 16, 1981 | K803305 | DUPONT 'ACA' CREATINE KINASE VERIFIERS E.I. Dupont DE Nemours & Co., Inc. | JJT |
| Apr 10, 1980 | K800604 | CK ISOENZYME ELECTROPHORESIS CONTROL-I.D Beckman Instruments, Inc. | JJT |
| Oct 1, 1979 | K791723 | QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) Organon, Inc. | JJT |
| Aug 16, 1979 | K791300 | LDH ISOENZYME CONTROL Electrophoresis Corp. of America | JJT |
| Aug 16, 1979 | K791299 | CPK ISOENZYME CONTROL Electrophoresis Corp. of America | JJT |
| Jul 17, 1979 | K790985 | P.A.P. RIA CONTROL SERUM PACK Mallinckrodt Critical Care | JJT |
| Aug 14, 1978 | K781100 | DELTA TEST AMYLASE/LIPASE CONTS. I,II Bd Becton Dickinson Vacutainer Systems Preanalytic | JJT |
| Jun 13, 1978 | K780801 | ISOZYME - ID CPK MARKER Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Jun 6, 1978 | K780554 | CLIN. CHEM. CONTROL SERUM-QUANTITATE Beckman Instruments, Inc. | JJT |
| Mar 3, 1978 | K780204 | CHEMISTRY CONTROL & REFERENCE SERUMS Hyland Therapeutic Div., Travenol Laboratories | JJT |
| Feb 23, 1978 | K780147 | ISOENZYME SERUM CONTROL Corning Medical & Scientific | JJT |
| Oct 25, 1977 | K771800 | ACA GLUTAMYL TRANSFERASE E.I. Dupont DE Nemours & Co., Inc. | JJT |
| Oct 19, 1977 | K771740 | CARDIOZYME CK-CONTROL LEVEL 1 Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Sep 2, 1977 | K771439 | PATHONORM H & L Nyegaard & Co. A/S | JJT |
| Sep 2, 1977 | K771438 | AUTONORM Nyegaard & Co. A/S | JJT |
| Sep 2, 1977 | K771436 | SERONORM Nyegaard & Co. A/S | JJT |
| Aug 4, 1977 | K770973 | CARDIOZYME CK CONTROL NORMAL Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Aug 4, 1977 | K770971 | CARDIOZYME CK-CONTROL ABNORMAL Dade, Baxter Travenol Diagnostics, Inc. | JJT |
| Jun 3, 1977 | K770555 | CPK ISOENZYME CONTROL Bio-Reagents & Diagnostics, Inc. | JJT |
| Jan 26, 1977 | K770049 | LDH ISOTROL T Sigma Chemical Co. | JJT |
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