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FDA 510(k)

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA

K-Number: K912940 · 1991-07-24

ApplicantDiagnostic Products Corp.
Decision Date1991-07-24
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K912940. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA?

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K912940.

When did COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA receive FDA 510(k) clearance?

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA received FDA 510(k) clearance on 1991-07-24, under 510(k) number K912940.

Who is the listed applicant for COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA?

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

What is the FDA product code for COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA?

The FDA product code for COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA is JZG.

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Other records listing Diagnostic Products Corp. 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: JZG)

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.

K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc.K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K110874ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083289HUMAN BETA-2 MICROGLOBULIN KITThe Binding Site, Ltd.K083463DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL MSiemens Healthcare DiagnosticsK072078QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307Biokit, S.A.

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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