510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933996Substantially Equivalent

Profiblot

Tecan U.S., Hillsborough NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933996 is the FDA 510(k) clearance record for PROFIBLOT, a class I device, cleared for Tecan U.S., Ltd. on under FDA product code KPA (Slide Stainer, Automated). FDA records list 10 510(k) clearances for Tecan U.S., Ltd., from to . As of , FDA records show no recalls naming K933996.

Clearance record

Decision date
Received
(164 days to decision)
Product code
KPA Slide Stainer, Automated
Regulation
21 CFR 864.3800
Device class
Class I
Review panel
Pathology
Applicant
Tecan U.S., Ltd. P.O. Box 8101, Hillsborough NC
510(k) summary
Statement
Third party review
No

Clearances, product code KPA

Trailing 12 months

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

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