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)

BIOLOGICAL/CHEMICAL INDICATOR

K-Number: K772135 · 1977-12-08

ApplicantAmsco Co.
Decision Date1977-12-08
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOLOGICAL/CHEMICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Co.. It received FDA 510(k) clearance on 1977-12-08 under 510(k) number K772135. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLOGICAL/CHEMICAL INDICATOR?

BIOLOGICAL/CHEMICAL INDICATOR is a medical device that received FDA 510(k) clearance on 1977-12-08. The listed applicant is Amsco Co.. The 510(k) number is K772135.

When did BIOLOGICAL/CHEMICAL INDICATOR receive FDA 510(k) clearance?

BIOLOGICAL/CHEMICAL INDICATOR received FDA 510(k) clearance on 1977-12-08, under 510(k) number K772135.

Who is the listed applicant for BIOLOGICAL/CHEMICAL INDICATOR?

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

What is the FDA product code for BIOLOGICAL/CHEMICAL INDICATOR?

The FDA product code for BIOLOGICAL/CHEMICAL INDICATOR is JOJ.

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 Amsco Co. 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.

K912471EAGLE 3000 SDSK854922AMSCO POLARIS SLK833187HALL OSTEONK832945EAGLE 2000 STERILIZER SERIES GAS/AERAK832188HALL RECIPROCATORK832187HALL OSCILLATOR

View all 19 devices →

Related Devices (Code: JOJ)

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.

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

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.

↑