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FDA 510(k)

ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S

K-Number: K851308 · 1985-04-17

ApplicantTechnicon Instruments Corp.
Decision Date1985-04-17
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S 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 1985-04-17 under 510(k) number K851308. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S?

ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S is a medical device that received FDA 510(k) clearance on 1985-04-17. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K851308.

When did ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S receive FDA 510(k) clearance?

ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S received FDA 510(k) clearance on 1985-04-17, under 510(k) number K851308.

Who is the listed applicant for ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S?

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 ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S?

The FDA product code for ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S is CIX.

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Related Devices (Code: CIX)

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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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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