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FDA 510(k)

CSF TOTAL PROTEIN TEST SET #0340

K-Number: K780110 · 1978-03-03

ApplicantStanbio Laboratory
Decision Date1978-03-03
Product CodeJGQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CSF TOTAL PROTEIN TEST SET #0340 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1978-03-03 under 510(k) number K780110. The device is classified under product code JGQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSF TOTAL PROTEIN TEST SET #0340?

CSF TOTAL PROTEIN TEST SET #0340 is a medical device that received FDA 510(k) clearance on 1978-03-03. The listed applicant is Stanbio Laboratory. The 510(k) number is K780110.

When did CSF TOTAL PROTEIN TEST SET #0340 receive FDA 510(k) clearance?

CSF TOTAL PROTEIN TEST SET #0340 received FDA 510(k) clearance on 1978-03-03, under 510(k) number K780110.

Who is the listed applicant for CSF TOTAL PROTEIN TEST SET #0340?

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

What is the FDA product code for CSF TOTAL PROTEIN TEST SET #0340?

The FDA product code for CSF TOTAL PROTEIN TEST SET #0340 is JGQ.

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Other records listing Stanbio Laboratory as applicant

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Related Devices (Code: JGQ)

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.

K131051HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)Hitachi Chemical Diagnostics, Inc.K072638ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801Roche Diagnostics Corp.K071239TOTAL PROTEIN URINE/CSF GEN.3Roche DiagnosticsK981295UPROAbbott LaboratoriesK981682UPROAbbott LaboratoriesK925794TRACE MICROPROTEIN REAGENTTrace America, Inc.

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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