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FDA 510(k)

LD-1(IMMUNO) SEPARATION SET

K-Number: K851521 · 1985-05-10

ApplicantSeragen Diagnostics, Inc.
Decision Date1985-05-10
Product CodeCEX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LD-1(IMMUNO) SEPARATION SET 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 1985-05-10 under 510(k) number K851521. The device is classified under product code CEX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LD-1(IMMUNO) SEPARATION SET?

LD-1(IMMUNO) SEPARATION SET is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K851521.

When did LD-1(IMMUNO) SEPARATION SET receive FDA 510(k) clearance?

LD-1(IMMUNO) SEPARATION SET received FDA 510(k) clearance on 1985-05-10, under 510(k) number K851521.

Who is the listed applicant for LD-1(IMMUNO) SEPARATION SET?

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 LD-1(IMMUNO) SEPARATION SET?

The FDA product code for LD-1(IMMUNO) SEPARATION SET is CEX.

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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)K850209QUICK-LYTEK844743SERATEST ENA(RNP/SM) DETERMINATION

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Related Devices (Code: CEX)

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.

K872891LACTATE DEHYDROGENASE ISOENZYME 1Data Medical Associates, Inc.K842018ISO-SEP SYSTEMBerwick Medical Products, Inc.K821983TITAN GEL LDH ISOENZYME KITHelena LaboratoriesK821879ULTRACHEM T.P.Harleco DiagnosticsK800129CENTRIFICHEM CREATININEUnion Carbide Corp.K772356LDH ISOENZYME COLUMN REAGENT SETWorthington Biochemical Corp.

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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