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)

SPORTROL RAPID STERILITY INDICATOR

K-Number: K962649 · 1997-09-26

ApplicantNorth American Science Assoc., Inc.
Decision Date1997-09-26
Product CodeMTC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPORTROL RAPID STERILITY INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is North American Science Assoc., Inc.. It received FDA 510(k) clearance on 1997-09-26 under 510(k) number K962649. The device is classified under product code MTC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPORTROL RAPID STERILITY INDICATOR?

SPORTROL RAPID STERILITY INDICATOR is a medical device that received FDA 510(k) clearance on 1997-09-26. The listed applicant is North American Science Assoc., Inc.. The 510(k) number is K962649.

When did SPORTROL RAPID STERILITY INDICATOR receive FDA 510(k) clearance?

SPORTROL RAPID STERILITY INDICATOR received FDA 510(k) clearance on 1997-09-26, under 510(k) number K962649.

Who is the listed applicant for SPORTROL RAPID STERILITY INDICATOR?

The FDA 510(k) record lists North American Science Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPORTROL RAPID STERILITY INDICATOR?

The FDA product code for SPORTROL RAPID STERILITY INDICATOR is MTC.

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 North American Science Assoc., 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.

K113221NAMSA BIOLOGICAL INDICATOR SPORE STRIPSK113302NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORSK983451CHALLENGE TEST PACK

Related Devices (Code: MTC)

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.

K210481Instant 20s IndicatorTrue Indicating, LLC

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.

↑