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FDA 510(k)

POLYSTYRENE MICROTITER WELL IMMUNOSOR

K-Number: K832345 · 1983-11-25

ApplicantDiagnostic Reagent Tech.
Decision Date1983-11-25
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

POLYSTYRENE MICROTITER WELL 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 1983-11-25 under 510(k) number K832345. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSTYRENE MICROTITER WELL IMMUNOSOR?

POLYSTYRENE MICROTITER WELL IMMUNOSOR is a medical device that received FDA 510(k) clearance on 1983-11-25. The listed applicant is Diagnostic Reagent Tech.. The 510(k) number is K832345.

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

POLYSTYRENE MICROTITER WELL IMMUNOSOR received FDA 510(k) clearance on 1983-11-25, under 510(k) number K832345.

Who is the listed applicant for POLYSTYRENE MICROTITER WELL 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 WELL IMMUNOSOR?

The FDA product code for POLYSTYRENE MICROTITER WELL IMMUNOSOR is DGC.

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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 STRIK831984POLYSTYRENE MICRO-LITER PLATE-BIRCHTREEK832344POLYSTYRENE MICROTITER PLATE IMMUNO-K831496ALLERGEN IMMUNOSORBENTS IP SPECIFIC EK831774LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-K830005IP SPECIFIC G

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Related Devices (Code: DGC)

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.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, 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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