NORMLCERA
FDA 510(k) clearance K810268 · decided 1981-03-06
Clearance details
- K-number
- K810268
- Device name
- NORMLCERA
- Applicant
- Medical Specialties Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-02-02
- Decision date
- 1981-03-06
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- KIS
- Device class
- 1
- Regulation number
- 864.2800
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| ANIMAL AND HUMAN SERA (K881287) | Cell Culture Laboratories | 1988-04-05 |
| BOVINE CALF SERUM SUPPLEMENTED #A-2159 (K880471) | Hyclone Laboratories, Inc. | 1988-04-04 |
| BOVINE CALF SERUM CATALOG #A-2119 (K880470) | Hyclone Laboratories, Inc. | 1988-04-01 |
| SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT (K872847) | Candace Lane Corp. | 1987-08-10 |
| MLC NORMAL SERUM (K870580) | Rjo Biologicals, Inc. | 1987-04-08 |
| FETAL BOVINE SERUM (K870938) | Hyclone Laboratories, Inc. | 1987-03-31 |
| DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (K870467) | Hyclone Laboratories, Inc. | 1987-03-24 |
| CHARACTERIZED FETAL BOVINE SERUM #A-1115 (K870464) | Hyclone Laboratories, Inc. | 1987-03-24 |
| ADULT BOVINE SERUM (K870468) | Hyclone Laboratories, Inc. | 1987-03-24 |
| DEFINED FETAL BOVINE SERUM #A-1111 (K870463) | Hyclone Laboratories, Inc. | 1987-03-24 |
| DEFINED CALF BOVINE SERUM #A-2111 (K870466) | Hyclone Laboratories, Inc. | 1987-03-24 |
| 6/40 FETAL BOVINE SERUM #A-1110 (K870465) | Hyclone Laboratories, Inc. | 1987-03-24 |
Recalls involving this device
No recalls on record reference this clearance.