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FDA 510(k)

OPTIMATE IGM TEST

K-Number: K841814 · 1984-06-22

ApplicantMiles Laboratories, Inc.
Decision Date1984-06-22
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OPTIMATE IGM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K841814. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMATE IGM TEST?

OPTIMATE IGM TEST is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K841814.

When did OPTIMATE IGM TEST receive FDA 510(k) clearance?

OPTIMATE IGM TEST received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841814.

Who is the listed applicant for OPTIMATE IGM TEST?

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

What is the FDA product code for OPTIMATE IGM TEST?

The FDA product code for OPTIMATE IGM TEST is DFT.

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Other records listing Miles Laboratories, Inc. as applicant

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Related Devices (Code: DFT)

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.

K983132IGMAbbott LaboratoriesK962201QUANTEX IGMInstrumentation Laboratory COK955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems GroupK901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, 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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