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FDA 510(k)

LOW LEVEL HUMAN ALBUMIN TEST KITS

K-Number: K761225 · 1977-04-07

ApplicantIntl. Diagnostic Technology
Decision Date1977-04-07
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LOW LEVEL HUMAN ALBUMIN TEST KITS is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1977-04-07 under 510(k) number K761225. 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 LOW LEVEL HUMAN ALBUMIN TEST KITS?

LOW LEVEL HUMAN ALBUMIN TEST KITS is a medical device that received FDA 510(k) clearance on 1977-04-07. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K761225.

When did LOW LEVEL HUMAN ALBUMIN TEST KITS receive FDA 510(k) clearance?

LOW LEVEL HUMAN ALBUMIN TEST KITS received FDA 510(k) clearance on 1977-04-07, under 510(k) number K761225.

Who is the listed applicant for LOW LEVEL HUMAN ALBUMIN TEST KITS?

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

What is the FDA product code for LOW LEVEL HUMAN ALBUMIN TEST KITS?

The FDA product code for LOW LEVEL HUMAN ALBUMIN TEST KITS is DCF.

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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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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