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FDA 510(k)

DIFFERENTIAL I.M. SCREENING TEST

K-Number: K873297 · 1987-12-14

ApplicantSclavo, Inc.
Decision Date1987-12-14
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIFFERENTIAL I.M. SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1987-12-14 under 510(k) number K873297. 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 DIFFERENTIAL I.M. SCREENING TEST?

DIFFERENTIAL I.M. SCREENING TEST is a medical device that received FDA 510(k) clearance on 1987-12-14. The listed applicant is Sclavo, Inc.. The 510(k) number is K873297.

When did DIFFERENTIAL I.M. SCREENING TEST receive FDA 510(k) clearance?

DIFFERENTIAL I.M. SCREENING TEST received FDA 510(k) clearance on 1987-12-14, under 510(k) number K873297.

Who is the listed applicant for DIFFERENTIAL I.M. SCREENING TEST?

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

What is the FDA product code for DIFFERENTIAL I.M. SCREENING TEST?

The FDA product code for DIFFERENTIAL I.M. SCREENING TEST is KTN.

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Other records listing Sclavo, Inc. as applicant

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K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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

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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