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FDA 510(k)

IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064

K-Number: K874406 · 1987-11-25

ApplicantMedix Biotech, Inc.
Decision Date1987-11-25
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 is the device name listed in this FDA 510(k) record. The listed applicant is Medix Biotech, Inc.. It received FDA 510(k) clearance on 1987-11-25 under 510(k) number K874406. 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 IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064?

IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Medix Biotech, Inc.. The 510(k) number is K874406.

When did IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 receive FDA 510(k) clearance?

IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 received FDA 510(k) clearance on 1987-11-25, under 510(k) number K874406.

Who is the listed applicant for IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064?

The FDA 510(k) record lists Medix Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064?

The FDA product code for IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 is DGC.

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Other records listing Medix Biotech, Inc. as applicant

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K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)K952319CONTRAST & RAPID HCG URINE/SERUM TSTK932482MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KITK925436MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KITK924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100

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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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