MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048
FDA 510(k) clearance K883449 · decided 1988-08-29
Clearance details
- K-number
- K883449
- Device name
- MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048
- Applicant
- J R Scientific
- Decision
- Substantially Equivalent
- Date received
- 1988-08-15
- Decision date
- 1988-08-29
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KIT
- Device class
- 1
- Regulation number
- 864.2220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Woodland, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch J R Scientific
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| ABC, ABC-1X, ABC(TM) (K890482) | Cell Ent., Inc. | 1989-02-10 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.