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FDA 510(k)

ENZYMUN-TEST(R) IGE

K-Number: K863822 · 1986-10-29

ApplicantBoehringer Mannheim Corp.
Decision Date1986-10-29
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENZYMUN-TEST(R) IGE is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K863822. 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 ENZYMUN-TEST(R) IGE?

ENZYMUN-TEST(R) IGE is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K863822.

When did ENZYMUN-TEST(R) IGE receive FDA 510(k) clearance?

ENZYMUN-TEST(R) IGE received FDA 510(k) clearance on 1986-10-29, under 510(k) number K863822.

Who is the listed applicant for ENZYMUN-TEST(R) IGE?

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

What is the FDA product code for ENZYMUN-TEST(R) IGE?

The FDA product code for ENZYMUN-TEST(R) IGE is DGC.

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Other records listing Boehringer Mannheim 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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