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)

LSM AGAR

K-Number: K822558 · 1982-09-14

ApplicantGranite Diagnostics, Inc.
Decision Date1982-09-14
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LSM AGAR is the device name listed in this FDA 510(k) record. The listed applicant is Granite Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822558. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LSM AGAR?

LSM AGAR is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Granite Diagnostics, Inc.. The 510(k) number is K822558.

When did LSM AGAR receive FDA 510(k) clearance?

LSM AGAR received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822558.

Who is the listed applicant for LSM AGAR?

The FDA 510(k) record lists Granite Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LSM AGAR?

The FDA product code for LSM AGAR is JWX.

Other records listing Granite Diagnostics, 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.

K850969INHIBITORY MOLD AGAR PLATEK850970BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORAK833254STREPTOCOCCUS ID TRIPLATE SYSTEMK832365TCBS AGARK831349STREPTOCOCUS ID PLATEK830252DIPCHEX DIP-SLIDE CULTURE SYS

View all 47 devices →

Related Devices (Code: JWX)

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.

K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, 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.

↑