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FDA 510(k)

RRT TOTAL IGE TEST KIT

K-Number: K874541 · 1988-02-17

ApplicantIncstar Corp.
Decision Date1988-02-17
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RRT TOTAL IGE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1988-02-17 under 510(k) number K874541. 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 RRT TOTAL IGE TEST KIT?

RRT TOTAL IGE TEST KIT is a medical device that received FDA 510(k) clearance on 1988-02-17. The listed applicant is Incstar Corp.. The 510(k) number is K874541.

When did RRT TOTAL IGE TEST KIT receive FDA 510(k) clearance?

RRT TOTAL IGE TEST KIT received FDA 510(k) clearance on 1988-02-17, under 510(k) number K874541.

Who is the listed applicant for RRT TOTAL IGE TEST KIT?

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

What is the FDA product code for RRT TOTAL IGE TEST KIT?

The FDA product code for RRT TOTAL IGE TEST KIT is DGC.

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Other records listing Incstar 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.

K963289INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963297INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K963296INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K960367INCSTAR RUBELLA IGG ELISA ASSAYK960358INCSTAR RUBELLA IGG FAST ELISA ASSAYK960434INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

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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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