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FDA 510(k)

LAB-TEK FTA-ABS KIT

K-Number: K801928 · 1980-08-20

ApplicantMiles Laboratories, Inc.
Decision Date1980-08-20
Product CodeJWL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LAB-TEK FTA-ABS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801928. The device is classified under product code JWL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAB-TEK FTA-ABS KIT?

LAB-TEK FTA-ABS KIT is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K801928.

When did LAB-TEK FTA-ABS KIT receive FDA 510(k) clearance?

LAB-TEK FTA-ABS KIT received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801928.

Who is the listed applicant for LAB-TEK FTA-ABS KIT?

The FDA 510(k) record lists Miles Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAB-TEK FTA-ABS KIT?

The FDA product code for LAB-TEK FTA-ABS KIT is JWL.

Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: JWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K831296POLYCHACO FIA-ABS TEST FOR SYPHILISParasitic Disease ConsultantsK801959FTA-ABS TESTImmuno-Diagnostic Products, Inc.K802276FTA-ABS BIOPAKBioware Products

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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