Stabilized Enzyme Solutions
Solution, Stabilized Enzyme
Cooper Biomedical
The following data is part of a premarket notification filed by Cooper Biomedical with the FDA for Stabilized Enzyme Solutions.
Pre-market Notification Details
| Device ID | BK830008 |
| 510k Number | BK830008 |
| Device Name: | Stabilized Enzyme Solutions |
| Classification | Solution, Stabilized Enzyme |
| Applicant | Cooper Biomedical 1230 Wilson Drive West Chester, PA 19380 |
| Product Code | KSK |
| CFR Regulation Number | 864.9400 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-27 |
| Decision Date | 1983-06-21 |
NIH GUDID Devices
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