PLASMINOGEN RID TEST KIT
FDA 510(k) clearance K941346 · decided 1994-09-09
Clearance details
- K-number
- K941346
- Device name
- PLASMINOGEN RID TEST KIT
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-21
- Decision date
- 1994-09-09
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- DDX
- Device class
- 1
- Regulation number
- 866.5715
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BERICHROM(R) PLASMINOGEN (K884766) | Behring Diagnostics, Inc. | 1989-01-04 |
| IL TEST 97573-15, PLASMINOGEN ASSAY (K864212) | Instrumentation Laboratory CO | 1986-12-04 |
| COATEST PLASMINOGEN (K854572) | Kabivitrum, Inc. | 1986-02-26 |
| GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (K850410) | Warner-Lambert Co. | 1985-05-08 |
| DIACROM *PLG (K832591) | Wellcome Diagnostics | 1983-11-21 |
| ACA PLASMINOGEN TEST PACK (K812625) | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 |
| HELENA PLASMINOGEN QUIPLATE PROCEDURE (K811777) | Helena Laboratories | 1981-07-02 |
| PLASMINOGEN ASSAY (K781478) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-15 |
| LAS-R HUMAN PLASMINOGEN TEST (K772085) | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 |
Recalls involving this device
No recalls on record reference this clearance.