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FDA 510(k)

TITAN GEL IFE TRIVALENT ANTISERUM

K-Number: K891188 · 1989-03-22

ApplicantHelena Laboratories
Decision Date1989-03-22
Product CodeCFQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TITAN GEL IFE TRIVALENT ANTISERUM is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-03-22 under 510(k) number K891188. The device is classified under product code CFQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL IFE TRIVALENT ANTISERUM?

TITAN GEL IFE TRIVALENT ANTISERUM is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is Helena Laboratories. The 510(k) number is K891188.

When did TITAN GEL IFE TRIVALENT ANTISERUM receive FDA 510(k) clearance?

TITAN GEL IFE TRIVALENT ANTISERUM received FDA 510(k) clearance on 1989-03-22, under 510(k) number K891188.

Who is the listed applicant for TITAN GEL IFE TRIVALENT ANTISERUM?

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

What is the FDA product code for TITAN GEL IFE TRIVALENT ANTISERUM?

The FDA product code for TITAN GEL IFE TRIVALENT ANTISERUM is CFQ.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: CFQ)

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.

K981786IGA MININEPH ANTISERUMThe Binding Site, Ltd.K990551IGG FLEX REAGENT CARTRIDGEDade Behring, Inc.K990552IMMUNOGLOBULIN A TEST SYSTEMDade Behring, Inc.K990553IGM FLEX REAGENT CARTRIDGEDade Behring, Inc.K951013OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K951055OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENTOlympus America, 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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