IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
FDA 510(k) clearance K864213 · decided 1986-11-25
Clearance details
- K-number
- K864213
- Device name
- IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1986-10-28
- Decision date
- 1986-11-25
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LGP
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lexington, MA, 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 |
|---|---|---|
| GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (K850411) | Warner-Lambert Co. | 1985-05-08 |
| COATEST ANTIPLASMIN (K833890) | Kabivitrum, Inc. | 1984-01-30 |
| ALPHA-ANTIPLASM ASSAY (K802840) | American Dade | 1981-02-17 |
| PROTEOLYTIC ENZYME CONTROL (K803110) | American Dade | 1981-02-17 |
Recalls involving this device
No recalls on record reference this clearance.