The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Isocontrol Serum Ld-.
Device ID | K850211 |
510k Number | K850211 |
Device Name: | ISOCONTROL SERUM LD- |
Classification | Enzyme Controls (assayed And Unassayed) |
Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Contact | Debra Hofmeister |
Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
Product Code | JJT |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-15 |
Decision Date | 1985-02-07 |