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)

ACS APCT REAGENT, MODIFIED

K-Number: K926012 · 1993-04-27

ApplicantAnalytical Control Systems, Inc.
Decision Date1993-04-27
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS APCT REAGENT, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Control Systems, Inc.. It received FDA 510(k) clearance on 1993-04-27 under 510(k) number K926012. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS APCT REAGENT, MODIFIED?

ACS APCT REAGENT, MODIFIED is a medical device that received FDA 510(k) clearance on 1993-04-27. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K926012.

When did ACS APCT REAGENT, MODIFIED receive FDA 510(k) clearance?

ACS APCT REAGENT, MODIFIED received FDA 510(k) clearance on 1993-04-27, under 510(k) number K926012.

Who is the listed applicant for ACS APCT REAGENT, MODIFIED?

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

What is the FDA product code for ACS APCT REAGENT, MODIFIED?

The FDA product code for ACS APCT REAGENT, MODIFIED is GFO.

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 Analytical Control Systems, 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.

K961892SPECKTIN-LA TEST SETK941115ACS CARDIO-TROL CONTROLK940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLK940397ACS O DILVENT PROTEIN DILUTION MATRIXK930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORK925340COAGULATION CONTROL CONTAINING HEMOGLOBIN

View all 42 devices →

Related Devices (Code: GFO)

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.

K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.K193556Cryocheck Hex LAPrecision BiologicK160445HemosIL Silica Clotting TimeInstrumentation Laboratory COK053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.K060688HEMOSIL SYNTHASILInstrumentation Laboratory COK050221HEMOSIL SILICA CLOTTING TIMEInstrumentation Laboratory CO

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.

↑