510(k) K883502
- Device
- FETAL BOVINE SERUM, DEFINED NO. 110-1121
- Applicant
- J R SCIENTIFIC
- 510(k) number
- K883502
- Product code
- KIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-29
- Date received
- 1988-08-16
- Regulation
- 864.2220
- Classification name
- Media And Components, Synthetic Cell And Tissue Culture
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- G KONISH,PHD
- Address
- One Harter Ave., Suite B P.O. Box 1937 Woodland CA US 95695 95695
FDA Registration Numbers#
- 3017716384
- 3006236690
- 1528450
- 3031092085
- 3006158025
- 3038430126
- 3015715780
- 1123137
- 3004107906
- 1318354
- 1226230
- 3014588186
- 3005182157
- 1114298
- 3010512490
- 3005875593
- 3013221738
- 3039436068
- 3005182159
- 2022379
- 3035387168
- 1048735
- 3008496303
- 3008624479
- 3042175767
- 9614209
- 3036495174
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KIT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K892938 | AMNIO-GROW TM | Inovar Biologicals, Inc. | 1989-05-22 |
| K890701 | ENDOTHELIAL GROWTH MEDIUM (EGM) | Clonetics Corp. | 1989-02-24 |
| K890700 | MELANOCYTE GROWTH MEDIUM (MGM) | Clonetics Corp. | 1989-02-24 |
| K890482 | ABC, ABC-1X, ABC(TM) | Cell Ent., Inc. | 1989-02-10 |
| K884654 | ALPHACALF SERUM | Hyclone Laboratories, Inc. | 1988-11-30 |
| K884574 | DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 | Sigma Chemical Co. | 1988-11-22 |
| K884573 | HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 | Sigma Chemical Co. | 1988-11-22 |
| K884572 | RPMI-1640 HYBRI-MAX, PROD. NO. R5382 | Sigma Chemical Co. | 1988-11-22 |
| K883065 | ALLOPREP SYSTEM | Osteotech, Inc. | 1988-10-13 |
| K884031 | FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT | Regency Biotech | 1988-10-06 |
| K883951 | MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) | J R Scientific | 1988-09-30 |
| K883682 | CHANG MEDIUM (ADDITIONAL INDICATIONS) | Hana Biologics, Inc. | 1988-09-16 |
| K883627 | MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150 | J R Scientific | 1988-09-07 |
| K883623 | EX-CELL 300TM, CATALOG NO. 200-3600 | J R Scientific | 1988-09-07 |
| K883624 | EX-CELL 300TM, CATALOG NO. 200-3601 | J R Scientific | 1988-09-07 |
Legacy Summary#
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FDA Review#
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