510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990641Substantially Equivalent

Caltag Fetal Hemoglobin Test

Caltag Laboratories, Inc., Dowingtown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990641 is the FDA 510(k) clearance record for CALTAG FETAL HEMOGLOBIN TEST, a class II device, cleared for Caltag Laboratories, Inc. on under FDA product code GHQ (Stain, Fetal Hemoglobin). FDA records list 12 510(k) clearances for Caltag Laboratories, Inc., from to . As of , FDA records show one recall naming K990641.

Clearance record

Decision date
Received
(203 days to decision)
Product code
GHQ Stain, Fetal Hemoglobin
Regulation
21 CFR 864.7455
Device class
Class II
Review panel
Hematology
Applicant
Caltag Laboratories, Inc. 605 Dilworth Rd., Dowingtown PA
510(k) summary
Summary
Third party review
No

Clearances, product code GHQ

Trailing 12 months

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

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