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FDA 510(k)

IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES

K-Number: K883745 · 1988-11-30

ApplicantDiagnostic Products Corp.
Decision Date1988-11-30
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES 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 1988-11-30 under 510(k) number K883745. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES?

IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K883745.

When did IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES receive FDA 510(k) clearance?

IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES received FDA 510(k) clearance on 1988-11-30, under 510(k) number K883745.

Who is the listed applicant for IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES?

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 IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES?

The FDA product code for IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES is CGJ.

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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: CGJ)

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.

K052662ONE STEP FSH MENOPAUSAL TESTInd Diagnostic, Inc.K043599MOMENTS MENOPAUSE CHECK, MODEL 9113Phamatech, Inc.K041165FSH MENOPAUSE PREDICTOR TESTACON Laboratories, Inc.K040575PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112Phamatech, Inc.K030058EARLYDETECT MENOPAUSE TEST FOR FSHEarly Detect, Inc.K002450GENUA MENOPAUSE MONITOR TEST KITGenua 1944, 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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