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FDA 510(k)

MAT (TM) MICROALBUMIN TEST

K-Number: K875161 · 1988-02-17

ApplicantWampole Laboratories
Decision Date1988-02-17
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MAT (TM) MICROALBUMIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1988-02-17 under 510(k) number K875161. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAT (TM) MICROALBUMIN TEST?

MAT (TM) MICROALBUMIN TEST is a medical device that received FDA 510(k) clearance on 1988-02-17. The listed applicant is Wampole Laboratories. The 510(k) number is K875161.

When did MAT (TM) MICROALBUMIN TEST receive FDA 510(k) clearance?

MAT (TM) MICROALBUMIN TEST received FDA 510(k) clearance on 1988-02-17, under 510(k) number K875161.

Who is the listed applicant for MAT (TM) MICROALBUMIN TEST?

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

What is the FDA product code for MAT (TM) MICROALBUMIN TEST?

The FDA product code for MAT (TM) MICROALBUMIN TEST is DCF.

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Other records listing Wampole Laboratories 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.

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Related Devices (Code: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K113072TINA-QUANT ALBUMIN GEN.2Roche Diagnostics OperationsK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.

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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