510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842091Substantially Equivalent

Dispos. Acu-Cut Soft Tissue Biopsy

The Healthcare Group Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842091 is the FDA 510(k) clearance record for DISPOS. ACU-CUT SOFT TISSUE BIOPSY, cleared for The Healthcare Group Laboratories, Inc. on . FDA records list 29 510(k) clearances for The Healthcare Group Laboratories, Inc., from to . As of , FDA records show no recalls naming K842091.

Clearance record

Decision date
Received
(60 days to decision)
Review panel
Unknown
Applicant
The Healthcare Group Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No