The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for The Stago Viii Deficient Plasma Kit.
| Device ID | K892859 |
| 510k Number | K892859 |
| Device Name: | THE STAGO VIII DEFICIENT PLASMA KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Le, Phd |
| Correspondent | Le, Phd AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-18 |
| Decision Date | 1989-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13607450007258 | K892859 | 000 |