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FDA 510(k)

CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036

K-Number: K853144 · 1985-10-16

ApplicantPreco, Inc.
Decision Date1985-10-16
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 is the device name listed in this FDA 510(k) record. The listed applicant is Preco, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853144. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036?

CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Preco, Inc.. The 510(k) number is K853144.

When did CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 receive FDA 510(k) clearance?

CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853144.

Who is the listed applicant for CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036?

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

What is the FDA product code for CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036?

The FDA product code for CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 is KTN.

Related Clinical Trials

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Other records listing Preco, 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.

K852751TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TESTK853054RF CARD TESTK850604PRECO PREGNANCY RAPID CARD TEST, HEM #2028

Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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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