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FDA 510(k)

ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5

K-Number: K872801 · 1987-09-10

ApplicantDiagnostic Products Corp.
Decision Date1987-09-10
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 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 1987-09-10 under 510(k) number K872801. The device is classified under product code DGO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5?

ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 is a medical device that received FDA 510(k) clearance on 1987-09-10. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K872801.

When did ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 receive FDA 510(k) clearance?

ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 received FDA 510(k) clearance on 1987-09-10, under 510(k) number K872801.

Who is the listed applicant for ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5?

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 ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5?

The FDA product code for ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 is DGO.

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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: DGO)

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.

K943194IMMULITE(R) ALLERGY FOOD PANEL FP5EDiagnostic Products Corp.K920087IGE EIA TEST KITThe Binding Site, Ltd.K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIEDDiagnostic Products Corp.K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSIONQuidel Corp.K893125BECKMAN EPSILON(TM) IGE REAGENT KITBeckman Instruments, Inc.K860851ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEMNichols Institute Diagnostics

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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