FIBRI-PREST AUTOMATE HA34
System, Fibrinogen Determination
WELLCOME DIAGNOSTICS
The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Fibri-prest Automate Ha34.
Pre-market Notification Details
| Device ID | K840211 |
| 510k Number | K840211 |
| Device Name: | FIBRI-PREST AUTOMATE HA34 |
| Classification | System, Fibrinogen Determination |
| Applicant | WELLCOME DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-19 |
| Decision Date | 1984-03-02 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|
| 13607450006749 |
K840211 |
000 |
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