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FDA 510(k)

CHL

K-Number: K813615 · 1982-02-04

ApplicantDms Laboratories
Decision Date1982-02-04
Product CodeJSC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHL is the device name listed in this FDA 510(k) record. The listed applicant is Dms Laboratories. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K813615. The device is classified under product code JSC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHL?

CHL is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Dms Laboratories. The 510(k) number is K813615.

When did CHL receive FDA 510(k) clearance?

CHL received FDA 510(k) clearance on 1982-02-04, under 510(k) number K813615.

Who is the listed applicant for CHL?

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 CHL?

The FDA product code for CHL is JSC.

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: 33967246Clinical Implementation of Second-generation Minimally Invasive Image-guided Cochlear Implantation Surgery.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology ()

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: JSC)

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.

K850143SPORDEX CULTURE MEDIAAmerican Sterilizer Co.K842852BRAIN HEART INFUSION BROTHAnarobe SystemsK842849TRYPTICASE SOY BROTHAnarobe SystemsK841221BRAIN HEART INFUSION BROTHAnaerobe SystemsK841219SHOPPED MEAT CARBOHYDRATEAnaerobe SystemsK833300SABOURAUD BHI AGARAcumedia Manufacturers, 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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