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FDA 510(k)

PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS

K-Number: K871352 · 1987-04-22

ApplicantHelena Laboratories
Decision Date1987-04-22
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-04-22 under 510(k) number K871352. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS?

PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Helena Laboratories. The 510(k) number is K871352.

When did PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS receive FDA 510(k) clearance?

PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS received FDA 510(k) clearance on 1987-04-22, under 510(k) number K871352.

Who is the listed applicant for PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS?

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 PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS?

The FDA product code for PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS is DEW.

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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: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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