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FDA 510(k)

TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN

K-Number: K895808 · 1989-10-17

ApplicantTechnicon Instruments Corp.
Decision Date1989-10-17
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K895808. 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 TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN?

TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K895808.

When did TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN receive FDA 510(k) clearance?

TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895808.

Who is the listed applicant for TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN?

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

What is the FDA product code for TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN?

The FDA product code for TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN is DCF.

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Other records listing Technicon Instruments Corp. as applicant

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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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