ABC, ABC-1X, ABC(TM)
FDA 510(k) clearance K890482 · decided 1989-02-10
Clearance details
- K-number
- K890482
- Device name
- ABC, ABC-1X, ABC(TM)
- Applicant
- Cell Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-31
- Decision date
- 1989-02-10
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- KIT
- Device class
- 1
- Regulation number
- 864.2220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Derwood, MD, 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 |
|---|---|---|
| AMNIO-GROW TM (K892938) | Inovar Biologicals, Inc. | 1989-05-22 |
| ENDOTHELIAL GROWTH MEDIUM (EGM) (K890701) | Clonetics Corp. | 1989-02-24 |
| MELANOCYTE GROWTH MEDIUM (MGM) (K890700) | Clonetics Corp. | 1989-02-24 |
| ALPHACALF SERUM (K884654) | Hyclone Laboratories, Inc. | 1988-11-30 |
| HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (K884573) | Sigma Chemical Co. | 1988-11-22 |
| RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (K884572) | Sigma Chemical Co. | 1988-11-22 |
| DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (K884574) | Sigma Chemical Co. | 1988-11-22 |
| ALLOPREP SYSTEM (K883065) | Osteotech, Inc. | 1988-10-13 |
| FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (K884031) | Regency Biotech | 1988-10-06 |
| MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) (K883951) | J R Scientific | 1988-09-30 |
| CHANG MEDIUM (ADDITIONAL INDICATIONS) (K883682) | Hana Biologics, Inc. | 1988-09-16 |
| EX-CELL 301, CATALOG NO. 200-3651 (K883625) | J R Scientific | 1988-09-07 |
Recalls involving this device
No recalls on record reference this clearance.