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FDA 510(k)

SERATEST DNA DETERMINATION

K-Number: K842563 · 1984-10-25

ApplicantSeragen Diagnostics, Inc.
Decision Date1984-10-25
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERATEST DNA DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-10-25 under 510(k) number K842563. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERATEST DNA DETERMINATION?

SERATEST DNA DETERMINATION is a medical device that received FDA 510(k) clearance on 1984-10-25. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K842563.

When did SERATEST DNA DETERMINATION receive FDA 510(k) clearance?

SERATEST DNA DETERMINATION received FDA 510(k) clearance on 1984-10-25, under 510(k) number K842563.

Who is the listed applicant for SERATEST DNA DETERMINATION?

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

What is the FDA product code for SERATEST DNA DETERMINATION?

The FDA product code for SERATEST DNA DETERMINATION is LKJ.

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Other records listing Seragen Diagnostics, 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.

K872148VIVID CHLAMYDIA(TM)K851663QUICK-COUNT HEMATOLOGY CONTROLSK852260QUICK-CHEM CALIBRATION SETK851520CK/LD ISOENZYMES CONTROLS(HUMAN)K851521LD-1(IMMUNO) SEPARATION SETK850209QUICK-LYTE

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Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, 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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