The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Aptt Reagent.
Device ID | K904341 |
510k Number | K904341 |
Device Name: | APTT REAGENT |
Classification | Activated Partial Thromboplastin |
Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
Contact | Daniel E Lawson,phd |
Correspondent | Daniel E Lawson,phd SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
Product Code | GFO |
CFR Regulation Number | 864.7925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-20 |
Decision Date | 1990-11-08 |