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FDA 510(k)

IMMULITE(R) ALLERGY FOOD PANEL FP5E

K-Number: K943194 · 1995-02-23

ApplicantDiagnostic Products Corp.
Decision Date1995-02-23
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE(R) ALLERGY FOOD PANEL FP5E 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 1995-02-23 under 510(k) number K943194. 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 IMMULITE(R) ALLERGY FOOD PANEL FP5E?

IMMULITE(R) ALLERGY FOOD PANEL FP5E is a medical device that received FDA 510(k) clearance on 1995-02-23. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K943194.

When did IMMULITE(R) ALLERGY FOOD PANEL FP5E receive FDA 510(k) clearance?

IMMULITE(R) ALLERGY FOOD PANEL FP5E received FDA 510(k) clearance on 1995-02-23, under 510(k) number K943194.

Who is the listed applicant for IMMULITE(R) ALLERGY FOOD PANEL FP5E?

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(R) ALLERGY FOOD PANEL FP5E?

The FDA product code for IMMULITE(R) ALLERGY FOOD PANEL FP5E is DGO.

Related Clinical Trials

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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

View all 321 devices →

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.

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.K872801ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5Diagnostic Products Corp.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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