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FDA 510(k)

STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

K-Number: K020138 · 2002-02-11

ApplicantGds Technology
Decision Date2002-02-11
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 is the device name listed in this FDA 510(k) record. The listed applicant is Gds Technology. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K020138. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090?

STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Gds Technology. The 510(k) number is K020138.

When did STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 receive FDA 510(k) clearance?

STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 received FDA 510(k) clearance on 2002-02-11, under 510(k) number K020138.

Who is the listed applicant for STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090?

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

What is the FDA product code for STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090?

The FDA product code for STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 is KHG.

Related Clinical Trials

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Related Devices (Code: KHG)

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.

K221508AnemoCheck HomeSanguina, Inc.K163215AnemoCheckSanguina, LLCK042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.K001462CARESIDE HEMOGLOBINCareside, Inc.K994073HEMOSITE TEST SYSTEMGds Technology, LLCK973649HEMOSITE TEST SYSTEMGds Technology, LLC

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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