The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Factor Control [p].
| Device ID | K930959 |
| 510k Number | K930959 |
| Device Name: | FACTOR CONTROL [P] |
| Classification | Control, Plasma, Abnormal |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Loe B Le |
| Correspondent | Loe B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-24 |
| Decision Date | 1993-05-20 |