510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121905Substantially Equivalent

Alere Pbp2a Test

Alere Scarborough, Inc., Scarborough ME / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121905 is the FDA 510(k) clearance record for ALERE PBP2A TEST, a class II device, cleared for Alere Scarborough, Inc. on under FDA product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies). FDA records list 17 510(k) clearances for Alere Scarborough, Inc., from to . As of , FDA records show no recalls naming K121905.

Clearance record

Decision date
Received
(27 days to decision)
Product code
MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Alere Scarborough, Inc. 10 Southgate Rd., Scarborough ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MYI

Trailing 12 months

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

FDA records show no clearances under product code MYI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MYI, 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