510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093737Substantially Equivalent

Hemosil F11 & Fv DNA Control

Instrumentation Laboratory Co., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093737 is the FDA 510(k) clearance record for HEMOSIL F11 & FV DNA CONTROL, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code NZB (Quality Control Material, Genetics, Dna). FDA's definition for product code NZB reads: "Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical...". FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K093737.

Clearance record

Decision date
Received
(151 days to decision)
Product code
NZB Quality Control Material, Genetics, Dna
Regulation
21 CFR 866.5910
Device class
Class II
Review panel
Microbiology
Applicant
Instrumentation Laboratory CO 180 Bedford Rd., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZB

Trailing 12 months

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

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