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FDA 510(k)

STAPH KIT

K-Number: K853488 · 1985-08-28

ApplicantCulture Kits, Inc.
Decision Date1985-08-28
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAPH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Culture Kits, Inc.. It received FDA 510(k) clearance on 1985-08-28 under 510(k) number K853488. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAPH KIT?

STAPH KIT is a medical device that received FDA 510(k) clearance on 1985-08-28. The listed applicant is Culture Kits, Inc.. The 510(k) number is K853488.

When did STAPH KIT receive FDA 510(k) clearance?

STAPH KIT received FDA 510(k) clearance on 1985-08-28, under 510(k) number K853488.

Who is the listed applicant for STAPH KIT?

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

What is the FDA product code for STAPH KIT?

The FDA product code for STAPH KIT is JSI.

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 Culture Kits, 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.

K911846URI-THREE(TM), MODIFICATIONK854672CANDI-KIT TMK851225URINE DUOK852582GONI-KITK852480DERM-KITK851518MUELLER HINTON SENSITIVITY PLATE

View all 9 devices →

Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881572XL AGAR BASEAcumedia 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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