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FDA 510(k)

POLYSTYRENE MICROTITER PLATE IMMUNOSOR

K-Number: K830495 · 1983-04-05

ApplicantDiagnostic Reagent Tech.
Decision Date1983-04-05
Product CodeDGO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

POLYSTYRENE MICROTITER PLATE IMMUNOSOR is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagent Tech.. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830495. 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 POLYSTYRENE MICROTITER PLATE IMMUNOSOR?

POLYSTYRENE MICROTITER PLATE IMMUNOSOR is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is Diagnostic Reagent Tech.. The 510(k) number is K830495.

When did POLYSTYRENE MICROTITER PLATE IMMUNOSOR receive FDA 510(k) clearance?

POLYSTYRENE MICROTITER PLATE IMMUNOSOR received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830495.

Who is the listed applicant for POLYSTYRENE MICROTITER PLATE IMMUNOSOR?

The FDA 510(k) record lists Diagnostic Reagent Tech. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYSTYRENE MICROTITER PLATE IMMUNOSOR?

The FDA product code for POLYSTYRENE MICROTITER PLATE IMMUNOSOR is DGO.

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Other records listing Diagnostic Reagent Tech. 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.

K843302NEW ALLERG. COATED MICROFILTER WELL STRIK832345POLYSTYRENE MICROTITER WELL IMMUNOSORK831984POLYSTYRENE MICRO-LITER PLATE-BIRCHTREEK832344POLYSTYRENE MICROTITER PLATE IMMUNO-K831496ALLERGEN IMMUNOSORBENTS IP SPECIFIC EK831774LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-

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

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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