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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