The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Referee Bft Blood For Tonometry.
Device ID | K792447 |
510k Number | K792447 |
Device Name: | REFEREE BFT BLOOD FOR TONOMETRY |
Classification | Controls For Blood-gases, (assayed And Unassayed) |
Applicant | ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJS |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-30 |
Decision Date | 1979-12-27 |