The following data is part of a premarket notification filed by Ac Biochemicals, Inc. with the FDA for Hdlc Precipitating Reagent.
| Device ID | K982539 |
| 510k Number | K982539 |
| Device Name: | HDLC PRECIPITATING REAGENT |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | AC BIOCHEMICALS, INC. 17955 SKY PARK CIRCLE, SUITE J Irvine, CA 92614 |
| Contact | C. C Allain |
| Correspondent | C. C Allain AC BIOCHEMICALS, INC. 17955 SKY PARK CIRCLE, SUITE J Irvine, CA 92614 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-21 |
| Decision Date | 1998-09-15 |