Company ยท US
Immunoprobe, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1997. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 5 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 4 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 1997 | K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM Immunoprobe, Inc. | GOD |
| Jul 14, 1997 | K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM Immunoprobe, Inc. | LJZ |
| Aug 19, 1996 | K961765 | MPO ELISA TEST SYSTEM Immunoprobe, Inc. | MOB |
| Aug 19, 1996 | K961764 | PR-3 ELISA TEST SYSTEM Immunoprobe, Inc. | MOB |
| Apr 29, 1996 | K951549 | EBNA IGG EIA TEST SYSTEM Immunoprobe, Inc. | LLM |
| 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 |
| Nov 20, 1995 | K951364 | MICROSOMAL EIA TEST KIT Immunoprobe, Inc. | JNL |
| Nov 20, 1995 | K951362 | THYROGLOBULIN EIA TEST KIT Immunoprobe, Inc. | JNL |
| Oct 13, 1995 | K951363 | CARDIOLIPIN IGG,M,A EIA TEST SYSTEM Immunoprobe, Inc. | MID |
| Sep 15, 1995 | K952520 | CARDIOLIPIN IGG,M,A EIA TEST KIT Immunoprobe, Inc. | MID |
| May 11, 1994 | K941361 | MICROSOMAL EIA TEST KIT Immunoprobe, Inc. | JNL |
| May 11, 1994 | K941358 | THYROGLOBULIN EIA TEST KIT Immunoprobe, Inc. | JNL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||