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FDA 510(k)

SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)

K-Number: K921939 · 1992-07-16

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-07-16
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-07-16 under 510(k) number K921939. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)?

SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) is a medical device that received FDA 510(k) clearance on 1992-07-16. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K921939.

When did SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) receive FDA 510(k) clearance?

SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) received FDA 510(k) clearance on 1992-07-16, under 510(k) number K921939.

Who is the listed applicant for SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)?

The FDA product code for SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) is LAS.

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Other records listing Heraeus Kulzer, Inc. 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics 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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