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FDA 510(k)

DIPCHEX DIP-SLIDE CULTURE SYS

K-Number: K830252 · 1983-03-07

ApplicantGranite Diagnostics, Inc.
Decision Date1983-03-07
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIPCHEX DIP-SLIDE CULTURE SYS 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 1983-03-07 under 510(k) number K830252. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIPCHEX DIP-SLIDE CULTURE SYS?

DIPCHEX DIP-SLIDE CULTURE SYS is a medical device that received FDA 510(k) clearance on 1983-03-07. The listed applicant is Granite Diagnostics, Inc.. The 510(k) number is K830252.

When did DIPCHEX DIP-SLIDE CULTURE SYS receive FDA 510(k) clearance?

DIPCHEX DIP-SLIDE CULTURE SYS received FDA 510(k) clearance on 1983-03-07, under 510(k) number K830252.

Who is the listed applicant for DIPCHEX DIP-SLIDE CULTURE SYS?

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 DIPCHEX DIP-SLIDE CULTURE SYS?

The FDA product code for DIPCHEX DIP-SLIDE CULTURE SYS is JXA.

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Other records listing Granite Diagnostics, Inc. as applicant

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K850969INHIBITORY MOLD AGAR PLATEK850970BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORAK833254STREPTOCOCCUS ID TRIPLATE SYSTEMK832365TCBS AGARK831349STREPTOCOCUS ID PLATEK830251CAMPY BLOOD AGAR PLATE

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Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)Izon Business Products, 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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