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FDA 510(k)

BIOGRAM

K-Number: K854521 · 1985-12-23

ApplicantGiles Scientific, Inc.
Decision Date1985-12-23
Product CodeJTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Giles Scientific, Inc.. It received FDA 510(k) clearance on 1985-12-23 under 510(k) number K854521. The device is classified under product code JTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGRAM?

BIOGRAM is a medical device that received FDA 510(k) clearance on 1985-12-23. The listed applicant is Giles Scientific, Inc.. The 510(k) number is K854521.

When did BIOGRAM receive FDA 510(k) clearance?

BIOGRAM received FDA 510(k) clearance on 1985-12-23, under 510(k) number K854521.

Who is the listed applicant for BIOGRAM?

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

What is the FDA product code for BIOGRAM?

The FDA product code for BIOGRAM is JTZ.

Related Clinical Trials

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Other records listing Giles Scientific, 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.

K944319BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEMK932122BIOMIC VIDEO PLATE READERK843725BIOGRAM

Related Devices (Code: JTZ)

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.

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton BrothBecton Dickinson and CompanyK963036MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOODBecton Dickinson Microbiology SystemsK960420MUELLER HINTON AGAR WITH 5% SHEEP BLOODBecton Dickinson Microbiology SystemsK960313MUELLER HINTON AGAR WITH 2% NACIRemel, L.P.K945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSBioclinical Systems, Inc.K941985MUELLER HINTON AGAR W/OXACILLINCarr-Scarborough Microbiologicals, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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