Immunoprobe, Inc.
Washington, D.C., DC, US
Immunoprobe, Inc. appears in FDA device records in Washington, D.C., DC. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Immunoprobe, Inc. between 1994 and 1997. The busiest year on record is 1996, with 6. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 6 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | GOD | Substantially Equivalent | |
| K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM | LJZ | Substantially Equivalent | |
| K961765 | MPO ELISA TEST SYSTEM | MOB | Substantially Equivalent | |
| K961764 | PR-3 ELISA TEST SYSTEM | MOB | Substantially Equivalent | |
| K951549 | EBNA IGG EIA TEST SYSTEM | LLM | Substantially Equivalent | |
| K952523 | CARDIOLIPIN IGG EIA TEST KIT | MID | Substantially Equivalent | |
| K952522 | CARDIOLIPIN IGA EIA TEST SYSTEM | MID | Substantially Equivalent | |
| K952521 | CARDIOLIPIN IGM EIA TEST SYSTEM | MID | Substantially Equivalent | |
| K951364 | MICROSOMAL EIA TEST KIT | JNL | Substantially Equivalent | |
| K951362 | THYROGLOBULIN EIA TEST KIT | JNL | Substantially Equivalent | |
| K951363 | CARDIOLIPIN IGG,M,A EIA TEST SYSTEM | MID | Substantially Equivalent | |
| K952520 | CARDIOLIPIN IGG,M,A EIA TEST KIT | MID | Substantially Equivalent | |
| K941361 | MICROSOMAL EIA TEST KIT | JNL | Substantially Equivalent | |
| K941358 | THYROGLOBULIN EIA TEST KIT | JNL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- JNLImmunochemical, Thyroglobulin Autoantibody
- MIDSystem, Test, Anticardiolipin Immunological
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain