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FDA 510(k)

QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD

K-Number: K901453 · 1990-04-12

ApplicantIsolab, Inc.
Decision Date1990-04-12
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1990-04-12 under 510(k) number K901453. 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 QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD?

QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD is a medical device that received FDA 510(k) clearance on 1990-04-12. The listed applicant is Isolab, Inc.. The 510(k) number is K901453.

When did QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD receive FDA 510(k) clearance?

QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD received FDA 510(k) clearance on 1990-04-12, under 510(k) number K901453.

Who is the listed applicant for QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD?

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

What is the FDA product code for QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD?

The FDA product code for QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD is DFT.

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Other records listing Isolab, 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.

K951014ISOLAB'S T4 TEST KITK950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITK943547PHENYLALANINE TEST KITK950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLEK950415FLUOROSCAN NEONATALK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

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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 GroupK894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, Inc.K884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MOrion Diagnostica, 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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