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FDA 510(k)

ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED

K-Number: K911511 · 1991-04-17

ApplicantDiagnostic Products Corp.
Decision Date1991-04-17
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED 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 1991-04-17 under 510(k) number K911511. 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 ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED?

ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED is a medical device that received FDA 510(k) clearance on 1991-04-17. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K911511.

When did ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED receive FDA 510(k) clearance?

ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED received FDA 510(k) clearance on 1991-04-17, under 510(k) number K911511.

Who is the listed applicant for ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED?

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 ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED?

The FDA product code for ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED 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.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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