510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972030Substantially Equivalent

Staphytect Plus/dryspot Staphytect Plus

Oxoid, Ltd., Basingstoke, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972030 is the FDA 510(k) clearance record for STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS, a class I device, cleared for Oxoid , Ltd. on under FDA product code JWX (Kit, Screening, Staphylococcus Aureus). FDA records list 36 510(k) clearances for Oxoid , Ltd., from to . As of , FDA records show one recall naming K972030.

Clearance record

Decision date
Received
(98 days to decision)
Product code
JWX Kit, Screening, Staphylococcus Aureus
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Oxoid , Ltd. Wade Rd., Basingstoke, GB
510(k) summary
Statement
Third party review
No

Clearances, product code JWX

Trailing 12 months

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

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