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FDA 510(k)

SLIDE CULTURE U 'EIKEN'

K-Number: K861631 · 1986-06-10

ApplicantSyn-Kit, Inc.
Decision Date1986-06-10
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SLIDE CULTURE U 'EIKEN' is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1986-06-10 under 510(k) number K861631. 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 SLIDE CULTURE U 'EIKEN'?

SLIDE CULTURE U 'EIKEN' is a medical device that received FDA 510(k) clearance on 1986-06-10. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K861631.

When did SLIDE CULTURE U 'EIKEN' receive FDA 510(k) clearance?

SLIDE CULTURE U 'EIKEN' received FDA 510(k) clearance on 1986-06-10, under 510(k) number K861631.

Who is the listed applicant for SLIDE CULTURE U 'EIKEN'?

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

What is the FDA product code for SLIDE CULTURE U 'EIKEN'?

The FDA product code for SLIDE CULTURE U 'EIKEN' is JXA.

Related Clinical Trials

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.

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GKK843753UROPAPER EIKEN GP

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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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