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FDA 510(k)

IMMULITE HCG HIGH LEVEL CONTROL MODULE

K-Number: K952251 · 1995-09-08

ApplicantDiagnostic Products Corp.
Decision Date1995-09-08
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE HCG HIGH LEVEL CONTROL MODULE 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 1995-09-08 under 510(k) number K952251. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE HCG HIGH LEVEL CONTROL MODULE?

IMMULITE HCG HIGH LEVEL CONTROL MODULE is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K952251.

When did IMMULITE HCG HIGH LEVEL CONTROL MODULE receive FDA 510(k) clearance?

IMMULITE HCG HIGH LEVEL CONTROL MODULE received FDA 510(k) clearance on 1995-09-08, under 510(k) number K952251.

Who is the listed applicant for IMMULITE HCG HIGH LEVEL CONTROL MODULE?

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 IMMULITE HCG HIGH LEVEL CONTROL MODULE?

The FDA product code for IMMULITE HCG HIGH LEVEL CONTROL MODULE is JJX.

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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: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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