EZ COMPLEMENT REAGENTS, 78N2212
FDA 510(k) clearance K870351 · decided 1987-03-13
Clearance details
- K-number
- K870351
- Device name
- EZ COMPLEMENT REAGENTS, 78N2212
- Applicant
- Diamedix Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-29
- Decision date
- 1987-03-13
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- DHL
- Device class
- 1
- Regulation number
- 866.4100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Miami, FL, 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 |
|---|---|---|
| KALLESTAD R QUANTIPLATE ALT. PATHWAY T. (K811445) | Kallestad Laboratories, Inc. | 1981-06-24 |
| SCRIPPSERA COMPLEMENT CONTROL SERA (K811433) | Scripps-Miles, Inc. | 1981-06-16 |
| RABBIT COMPLEMENT (K770866) | Cedarlake Labs , Ltd. | 1977-06-03 |
Recalls involving this device
No recalls on record reference this clearance.