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FDA 510(k)

TOUCH TEAR IGE MICROASSAY KIT

K-Number: K991316 · 1999-08-09

ApplicantTouch Scientific, Inc.
Decision Date1999-08-09
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TOUCH TEAR IGE MICROASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Touch Scientific, Inc.. It received FDA 510(k) clearance on 1999-08-09 under 510(k) number K991316. 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 TOUCH TEAR IGE MICROASSAY KIT?

TOUCH TEAR IGE MICROASSAY KIT is a medical device that received FDA 510(k) clearance on 1999-08-09. The listed applicant is Touch Scientific, Inc.. The 510(k) number is K991316.

When did TOUCH TEAR IGE MICROASSAY KIT receive FDA 510(k) clearance?

TOUCH TEAR IGE MICROASSAY KIT received FDA 510(k) clearance on 1999-08-09, under 510(k) number K991316.

Who is the listed applicant for TOUCH TEAR IGE MICROASSAY KIT?

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

What is the FDA product code for TOUCH TEAR IGE MICROASSAY KIT?

The FDA product code for TOUCH TEAR IGE MICROASSAY 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 Touch Scientific, 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.

K934473LACTOFERRIN MICROASSAY SYSTEMK931901LACTOCARD

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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