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 |