RABBIT COMPLEMENT
FDA 510(k) clearance K812522 · decided 1981-09-23
Clearance details
- K-number
- K812522
- Device name
- RABBIT COMPLEMENT
- Applicant
- Dutchland Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-02
- Decision date
- 1981-09-23
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KTQ
- Device class
- 1
- Regulation number
- 866.4100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (K890417) | Atlantic Antibodies | 1989-02-17 |
| GUINEA PIG COMPLEMENT REGULAR (K812370) | Dutchland Laboratories, Inc. | 1981-09-08 |
| GUINEA PIG COMPLEMENT VIRUS ANTIBODY (K812369) | Dutchland Laboratories, Inc. | 1981-09-08 |
| RABBIT COMPLEMENT (K791117) | Calbiochem-Behring Corp. | 1979-08-03 |
| LOW-TOX-H RABBIT COMPLEMENT (K790380) | Cederlane Labs , Ltd. | 1979-03-21 |
Recalls involving this device
No recalls on record reference this clearance.