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FDA 510(k)

ULTRASCAN IGE ASSAY KIT

K-Number: K872968 · 1987-08-28

ApplicantSpecialty Medical Industries, Inc.
Decision Date1987-08-28
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ULTRASCAN IGE ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Medical Industries, Inc.. It received FDA 510(k) clearance on 1987-08-28 under 510(k) number K872968. 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 ULTRASCAN IGE ASSAY KIT?

ULTRASCAN IGE ASSAY KIT is a medical device that received FDA 510(k) clearance on 1987-08-28. The listed applicant is Specialty Medical Industries, Inc.. The 510(k) number is K872968.

When did ULTRASCAN IGE ASSAY KIT receive FDA 510(k) clearance?

ULTRASCAN IGE ASSAY KIT received FDA 510(k) clearance on 1987-08-28, under 510(k) number K872968.

Who is the listed applicant for ULTRASCAN IGE ASSAY KIT?

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

What is the FDA product code for ULTRASCAN IGE ASSAY KIT?

The FDA product code for ULTRASCAN IGE ASSAY KIT is DGC.

Related Clinical Trials

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.

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Other records listing Specialty Medical Industries, Inc. 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.

K862999ULTRASCAN CLINICAL ANALYZERK790808PROTEIN ASSAY KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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