510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060968Substantially Equivalent

Stasis - I, II and III; Serathan - a, B; Intrin - Ea, Si Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low

Wortham Laboratories, Inc., Chattanooga TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060968 is the FDA 510(k) clearance record for STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW, a class II device, cleared for Wortham Laboratories, Inc. on under FDA product code GIZ (Plasma, Control, Normal). FDA records list one 510(k) clearance for Wortham Laboratories, Inc. As of , FDA records show no recalls naming K060968.

Clearance record

Decision date
Received
(403 days to decision)
Product code
GIZ Plasma, Control, Normal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Wortham Laboratories, Inc. 6340 Bonny Oaks Dr., Chattanooga TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GIZ

Trailing 12 months

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

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