510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972884Substantially Equivalent

Accurun 146 Cmv Igm Positive Control

Boston Biomedica, Inc., West Bridgewater MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972884 is the FDA 510(k) clearance record for ACCURUN 146 CMV IGM POSITIVE CONTROL, a class II device, cleared for Boston Biomedica, Inc. on under FDA product code LKQ (Antibody Igm,If, Cytomegalovirus Virus). FDA records list 12 510(k) clearances for Boston Biomedica, Inc., from to . As of , FDA records show no recalls naming K972884.

Clearance record

Decision date
Received
(17 days to decision)
Product code
LKQ Antibody Igm,If, Cytomegalovirus Virus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Boston Biomedica, Inc. 375 W. St., West Bridgewater MA
510(k) summary
Summary
Third party review
No

Clearances, product code LKQ

Trailing 12 months

FDA records hold no clearances under product code LKQ in the trailing twelve months.

FDA records show no clearances under product code LKQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260