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FDA 510(k)

SELECTICULT-CHLAMYDIA

K-Number: K852869 · 1985-09-19

ApplicantScott Laboratories, Inc.
Decision Date1985-09-19
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SELECTICULT-CHLAMYDIA is the device name listed in this FDA 510(k) record. The listed applicant is Scott Laboratories, Inc.. It received FDA 510(k) clearance on 1985-09-19 under 510(k) number K852869. The device is classified under product code LKH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTICULT-CHLAMYDIA?

SELECTICULT-CHLAMYDIA is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Scott Laboratories, Inc.. The 510(k) number is K852869.

When did SELECTICULT-CHLAMYDIA receive FDA 510(k) clearance?

SELECTICULT-CHLAMYDIA received FDA 510(k) clearance on 1985-09-19, under 510(k) number K852869.

Who is the listed applicant for SELECTICULT-CHLAMYDIA?

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

What is the FDA product code for SELECTICULT-CHLAMYDIA?

The FDA product code for SELECTICULT-CHLAMYDIA is LKH.

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Other records listing Scott Laboratories, 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.

K880694B. CAT CONFIRMK874933MUG-INDOLE DISCK874662MYCO-FLUOR REAGENT A & BK873509IDENTICULT-BLK871238ANABAGK863025SERO-STAT R II STAPHYLOCOCCUS TEST

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Related Devices (Code: LKH)

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.

K910644IPAZYME (TM) CHLAMYDIA IGG-IGASavyon Diagnostics , Ltd.K901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)Savyon Diagnostics , Ltd.K882674IMMU-MARK(TM) CHLAMYDIA IGG/IGA KITIcn ImmunobiologicalsK893669CELLMATICS SHLAMYDIA DETECTION SYSTEMDifco Laboratories, Inc.K842151CHLAMYDIAE IMMUNOPEROXIDASE TEST KITBartels Immunodiagnostic Supplies, Inc.K830688COMBION SKIN TESTNicholas H. Maganias

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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