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FDA 510(k)

RAPID ZYME

K-Number: K813612 · 1982-02-22

ApplicantDms Laboratories
Decision Date1982-02-22
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID ZYME is the device name listed in this FDA 510(k) record. The listed applicant is Dms Laboratories. It received FDA 510(k) clearance on 1982-02-22 under 510(k) number K813612. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID ZYME?

RAPID ZYME is a medical device that received FDA 510(k) clearance on 1982-02-22. The listed applicant is Dms Laboratories. The 510(k) number is K813612.

When did RAPID ZYME receive FDA 510(k) clearance?

RAPID ZYME received FDA 510(k) clearance on 1982-02-22, under 510(k) number K813612.

Who is the listed applicant for RAPID ZYME?

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

What is the FDA product code for RAPID ZYME?

The FDA product code for RAPID ZYME is JTO.

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 Dms Laboratories 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.

K831186RAPID NFTK831187TRPK830437CHSK823102AGAR PK821038FAST VIOLET BK813613RAPID CH

View all 23 devices →

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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.

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