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FDA 510(k)

BIOCHECK IGE ELISA, MODEL BC-1035

K-Number: K992528 · 1999-09-21

ApplicantBiocheck, Inc.
Decision Date1999-09-21
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BIOCHECK IGE ELISA, MODEL BC-1035 is the device name listed in this FDA 510(k) record. The listed applicant is Biocheck, Inc.. It received FDA 510(k) clearance on 1999-09-21 under 510(k) number K992528. 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 BIOCHECK IGE ELISA, MODEL BC-1035?

BIOCHECK IGE ELISA, MODEL BC-1035 is a medical device that received FDA 510(k) clearance on 1999-09-21. The listed applicant is Biocheck, Inc.. The 510(k) number is K992528.

When did BIOCHECK IGE ELISA, MODEL BC-1035 receive FDA 510(k) clearance?

BIOCHECK IGE ELISA, MODEL BC-1035 received FDA 510(k) clearance on 1999-09-21, under 510(k) number K992528.

Who is the listed applicant for BIOCHECK IGE ELISA, MODEL BC-1035?

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

What is the FDA product code for BIOCHECK IGE ELISA, MODEL BC-1035?

The FDA product code for BIOCHECK IGE ELISA, MODEL BC-1035 is DGC.

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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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