The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Pantrak E.k..
Device ID | K810669 |
510k Number | K810669 |
Device Name: | PANTRAK E.K. |
Classification | Starch-dye Bound Polymer, Amylase |
Applicant | CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CIW |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-12 |
Decision Date | 1981-03-31 |