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FDA 510(k)

TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410

K-Number: K872834 · 1987-08-12

ApplicantHelena Laboratories
Decision Date1987-08-12
Product CodeCZJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K872834. The device is classified under product code CZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410?

TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Helena Laboratories. The 510(k) number is K872834.

When did TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 receive FDA 510(k) clearance?

TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 received FDA 510(k) clearance on 1987-08-12, under 510(k) number K872834.

Who is the listed applicant for TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410?

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 ANTISERUM TO IGD-9409 & IGE-9410?

The FDA product code for TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 is CZJ.

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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: CZJ)

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.

K092450HUMAN IGD KIT FOR USE ON SPAPLUSThe Binding SiteK051299IGD DIAGNOSTIC TEST KITSThe Binding Site, Ltd.K002561SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KITThe Binding Site, Ltd.K913671HUMAN IGD IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.K883001QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.K831956DETERM. SIZE 72 RADIAL-HUMAN IGDKent Laboratories, 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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