DIACROM * ATIII
Antithrombin Iii Quantitation
WELLCOME DIAGNOSTICS
The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Diacrom * Atiii.
Pre-market Notification Details
| Device ID | K832592 |
| 510k Number | K832592 |
| Device Name: | DIACROM * ATIII |
| Classification | Antithrombin Iii Quantitation |
| Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-09-29 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|
| 03607450005967 |
K832592 |
000 |
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