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FDA 510(k)

IND

K-Number: K820210 · 1982-02-12

ApplicantDms Laboratories
Decision Date1982-02-12
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IND is the device name listed in this FDA 510(k) record. The listed applicant is Dms Laboratories. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820210. 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 IND?

IND is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Dms Laboratories. The 510(k) number is K820210.

When did IND receive FDA 510(k) clearance?

IND received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820210.

Who is the listed applicant for IND?

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 IND?

The FDA product code for IND is JTO.

Related PubMed Literature

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.

PMID: 42834824India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.Expert review of medical devices ()PMID: 42714465Artificial Intelligence in Indian Dermatology: An IADVL Academy Position Statement and Policy Framework for Safe, Equitable, and Effective Adoption.Indian dermatology online journal ()PMID: 42323480Patient Preference Information (PPI) in Medical Device Development: A Cross-Industry Review of Use-Cases.Therapeutic innovation & regulatory science ()PMID: 42222899Interpreting the two-hour partial REBOA safety window: Physiologic context, monitoring limitations, and device-specific considerations.The journal of trauma and acute care surgery ()

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.

K831187TRPK831186RAPID NFTK830437CHSK823102AGAR 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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