Fast'N'Flammatory Kit

FDA 510(k) K931241 · Techlab, Inc.

Substantially Equivalent

510(k) numberK931241

Submission

Device name
Fast'N'Flammatory Kit
Applicant
Techlab, Inc.
Blacksburg, VA, US
Received
March 11, 1993
Decision date
February 3, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GIA – Test, Leukocyte Peroxidase
Device class
Class I (low risk)
Regulation
21 CFR 864.7675
Specialty
Hematology

Other 510(k)s with product code GIA

510(k)DeviceApplicantDecision
K844402Sigma Peroxidase Myeloperoxidase Staining ProcedurGIA · Traditional Sigma Chemical Co.01/04/1985SE
K811011Histochemical Demonstration of LeukocyteGIA · Traditional Sigma Chemical Co.05/15/1981SE

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Questions and answers

When was Fast'N'Flammatory Kit cleared by the FDA?

Fast'N'Flammatory Kit (K931241) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 329 days after the submission was received.

What is the product code of K931241?

The FDA product code is GIA – Test, Leukocyte Peroxidase, a Class I (low risk) device regulated under 21 CFR 864.7675.