Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MD STRIPS BG

K-Number: K875049 · 1988-08-23

ApplicantAmatech International, Inc.
Decision Date1988-08-23
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MD STRIPS BG is the device name listed in this FDA 510(k) record. The listed applicant is Amatech International, Inc.. It received FDA 510(k) clearance on 1988-08-23 under 510(k) number K875049. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MD STRIPS BG?

MD STRIPS BG is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is Amatech International, Inc.. The 510(k) number is K875049.

When did MD STRIPS BG receive FDA 510(k) clearance?

MD STRIPS BG received FDA 510(k) clearance on 1988-08-23, under 510(k) number K875049.

Who is the listed applicant for MD STRIPS BG?

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

What is the FDA product code for MD STRIPS BG?

The FDA product code for MD STRIPS BG is CGA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Amatech International, 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.

K872704AMASTIM 2000K862806URINE DIAGNOSTIC REAGENT STRIPS

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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.

↑