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FDA 510(k)

KWIK-LAC BETA-LACTAMASE KITS

K-Number: K811442 · 1981-06-18

ApplicantWindsor Laboratories, Inc.
Decision Date1981-06-18
Product Code
DecisionSubstantially Equivalent

Device Summary

KWIK-LAC BETA-LACTAMASE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1981-06-18 under 510(k) number K811442. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KWIK-LAC BETA-LACTAMASE KITS?

KWIK-LAC BETA-LACTAMASE KITS is a medical device that received FDA 510(k) clearance on 1981-06-18. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K811442.

When did KWIK-LAC BETA-LACTAMASE KITS receive FDA 510(k) clearance?

KWIK-LAC BETA-LACTAMASE KITS received FDA 510(k) clearance on 1981-06-18, under 510(k) number K811442.

Who is the listed applicant for KWIK-LAC BETA-LACTAMASE KITS?

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

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Other records listing Windsor Laboratories, Inc. as applicant

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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK871486(FPIA) ASSAY BUFFERK870389DIGOXIN (FPIA) CALIBRATOR KITK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY

View all 19 devices →

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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