Panels › Immunology › Product code MID · Class 2
System, Test, Anticardiolipin Immunological
Regulation 866.5660
0510(k)s in 12 months (94 all time)
0recalls in 12 months (17 all time)
16recalls that name a 510(k)
Top companies in MID
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 1997 | K971784 | ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | MID |
| Jun 11, 1997 | K970177 | ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA Immco Diagnostics, Inc. | MID |
| Jun 3, 1997 | K971039 | HEMAGEN ANTI CARDIOLIPIN SCREEN Hemagen Diagnostics, Inc. | MID |
| Oct 10, 1996 | K962926 | ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY American Laboratory Products Co., Ltd. | MID |
| Sep 9, 1996 | K962469 | ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY American Laboratory Products Co., Ltd. | MID |
| May 30, 1996 | K955303 | DIASTAT ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd., GB | MID |
| May 23, 1996 | K955449 | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY American Laboratory Products Co., Ltd. | MID |
| Feb 9, 1996 | K952523 | CARDIOLIPIN IGG EIA TEST KIT Immunoprobe, Inc. | MID |
| Feb 9, 1996 | K952522 | CARDIOLIPIN IGA EIA TEST SYSTEM Immunoprobe, Inc. | MID |
| Feb 9, 1996 | K952521 | CARDIOLIPIN IGM EIA TEST SYSTEM Immunoprobe, Inc. | MID |
| Jan 24, 1996 | K946217 | CARDIOLIPIN M EIA TEST SYSTEM Hogan & Hartson | MID |
| Jan 24, 1996 | K946216 | CARDIOLIPIN A EIA TEST SYSTEM Hogan & Hartson | MID |
| Jan 24, 1996 | K946215 | CARDIOLIPIN G EIA TEST SYSTEM Hogan & Hartson | MID |
| Dec 18, 1995 | K952287 | REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT Reaads Medical Products, Inc. | MID |
| Oct 13, 1995 | K951363 | CARDIOLIPIN IGG,M,A EIA TEST SYSTEM Immunoprobe, Inc. | MID |
| Oct 2, 1995 | K951187 | VARELISA CARDIOLIPIN ABS SCREEN Elias U.S.A., Inc. | MID |
| Sep 15, 1995 | K952520 | CARDIOLIPIN IGG,M,A EIA TEST KIT Immunoprobe, Inc. | MID |
| Sep 1, 1995 | K953366 | QUANTA LITE IGA ACA (HRP) Inova Diagnostics, Inc. | MID |
| Aug 29, 1995 | K953291 | QUANTA LITE ACA SCREEN (HRP) Inova Diagnostics, Inc. | MID |
| Jul 18, 1995 | K946385 | QUANTA LITE ACA IGM (HRP) Inova Diagnostics, Inc. | MID |
| Jul 18, 1995 | K946034 | QUANTA LITE(TM) IGG (HRP) Inova Diagnostics, Inc. | MID |
| Mar 7, 1995 | K933788 | ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST Immco Diagnostics, Inc. | MID |
| Mar 7, 1995 | K933786 | ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST Immco Diagnostics, Inc. | MID |
| Mar 7, 1995 | K933784 | ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) Immco Diagnostics, Inc. | MID |
| Oct 13, 1994 | K933588 | APHLELISA KIT Louisville Apl Diagnostics, Inc. | MID |
| Sep 20, 1994 | K940403 | ELIAS CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| Jun 30, 1994 | K941840 | HEMAGEN ACL IGA CALIBRATOR Hemagen Diagnostics, Inc. | MID |
| Jan 24, 1994 | K935288 | SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| Dec 8, 1993 | K933393 | ELIAS CARDIOLIPIN IGG ANTIBODIES Elias U.S.A., Inc. | MID |
| Dec 8, 1993 | K933392 | ELIAS CARDIOLIPIN IGM ANTIBODIES Elias U.S.A., Inc. | MID |
| Jul 16, 1993 | K932373 | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 Hemagen Diagnostics, Inc. | MID |
| Jul 6, 1993 | K932225 | ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM Immuno Concepts, Inc. | MID |
| Nov 30, 1992 | K924421 | SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| Sep 29, 1992 | K922351 | QUANTA LITE(TM) IGA ACA Inova Diagnostics, Inc. | MID |
| Sep 28, 1992 | K923320 | QUANTA LITE ACA SCREEN Inova Diagnostics, Inc. | MID |
| Sep 25, 1992 | K923886 | DIASTAT TOTAL ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd., GB | MID |
| Aug 20, 1992 | K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST General Biometrics, Inc. | MID |
| Aug 20, 1992 | K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST General Biometrics, Inc. | MID |
| Aug 3, 1992 | K921265 | DIASTAT ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd., GB | MID |
| Jun 4, 1992 | K921250 | SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. | MID |
| Dec 18, 1991 | K914405 | READS(R) IGA ANTI-CARDIOLIPIN TEST KIT Reads Medical Products, Inc. | MID |
| Dec 9, 1991 | K911661 | ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM Immuno Concepts, Inc. | MID |
| Nov 27, 1991 | K913054 | 3M ANTI-CARDIOLIPIN FAST(TM) TEST 3M Diagnostic Systems, Inc. | MID |
| Nov 19, 1991 | K911680 | QUANTA LITE(TM) ACA Inova Diagnostics, Inc. | MID |
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