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FDA 510(k)

QUIK-SEP IGM ISOLATION SYSTEM

K-Number: K830606 · 1983-03-24

ApplicantIsolab, Inc.
Decision Date1983-03-24
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUIK-SEP IGM ISOLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830606. 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 IGM ISOLATION SYSTEM?

QUIK-SEP IGM ISOLATION SYSTEM is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Isolab, Inc.. The 510(k) number is K830606.

When did QUIK-SEP IGM ISOLATION SYSTEM receive FDA 510(k) clearance?

QUIK-SEP IGM ISOLATION SYSTEM received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830606.

Who is the listed applicant for QUIK-SEP IGM ISOLATION SYSTEM?

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 IGM ISOLATION SYSTEM?

The FDA product code for QUIK-SEP IGM ISOLATION SYSTEM 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 NEONATALK942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

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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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