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FDA 510(k)

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

K-Number: K891683 · 1989-04-12

ApplicantHelena Laboratories
Decision Date1989-04-12
Product CodeCZN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K891683. The device is classified under product code CZN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER?

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Helena Laboratories. The 510(k) number is K891683.

When did TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER receive FDA 510(k) clearance?

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER received FDA 510(k) clearance on 1989-04-12, under 510(k) number K891683.

Who is the listed applicant for TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER?

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 FREE KAPPA/LAMBA LIGHT CHAIN ANTISER?

The FDA product code for TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER is CZN.

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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: CZN)

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.

K855011QUANTIMETRIC PLUS C3 REAGENT KITKallestad Laboratories, Inc.K841815OPTIMATE IGA TESTMiles Laboratories, Inc.K832262FITC GOAT ANTI-HUMAN IMMUNOGLOBULINSGelco Diagnostics, Inc.K832257GOAT ANTI-HUMAN IGA A CHAIN SPECIFICGelco Diagnostics, Inc.K831909RABBIT ANTISERUM TO HUMAN IGADako Corp.K831607FIAX IGA TEST KITIntl. Diagnostic Technology

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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