510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K971944Substantially Equivalent

Lactest I

Jwt, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971944 is the FDA 510(k) clearance record for LACTEST I, a class I device, cleared for Jwt, Inc. on under FDA product code KHP (Acid, Lactic, Enzymatic Method). FDA records list one 510(k) clearance for Jwt, Inc. As of , FDA records show no recalls naming K971944.

Clearance record

Decision date
Received
(204 days to decision)
Product code
KHP Acid, Lactic, Enzymatic Method
Regulation
21 CFR 862.1450
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Jwt, Inc. 115 Research Dr., Bethlehem PA
510(k) summary
Statement
Third party review
No

Clearances, product code KHP

Trailing 12 months

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

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