The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Htf Medium, Modified Htf Medium- Hepes, Htf Powder (without Antibiotics), Modified Htg Powder- Hepes (without Antiboditi.
| Device ID | K983586 |
| 510k Number | K983586 |
| Device Name: | HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI |
| Classification | Media, Reproductive |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Roberta L Johnson |
| Correspondent | Roberta L Johnson IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893727002927 | K983586 | 000 |
| 00893727002910 | K983586 | 000 |
| 00893727002804 | K983586 | 000 |
| 00893727002194 | K983586 | 000 |