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FDA 510(k)

EMIT AAII THYROXINE CALIBRATORS

K-Number: K801287 · 1980-06-30

ApplicantSyva Co.
Decision Date1980-06-30
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMIT AAII THYROXINE CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801287. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT AAII THYROXINE CALIBRATORS?

EMIT AAII THYROXINE CALIBRATORS is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Syva Co.. The 510(k) number is K801287.

When did EMIT AAII THYROXINE CALIBRATORS receive FDA 510(k) clearance?

EMIT AAII THYROXINE CALIBRATORS received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801287.

Who is the listed applicant for EMIT AAII THYROXINE CALIBRATORS?

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

What is the FDA product code for EMIT AAII THYROXINE CALIBRATORS?

The FDA product code for EMIT AAII THYROXINE CALIBRATORS is JIS.

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Other records listing Syva Co. 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.

K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULK012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULK011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL

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Related Devices (Code: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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