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FDA 510(k)

SPIFE URINE IFE

K-Number: K982639 · 1998-11-04

ApplicantHelena Laboratories
Decision Date1998-11-04
Product CodeDAO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPIFE URINE IFE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1998-11-04 under 510(k) number K982639. The device is classified under product code DAO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIFE URINE IFE?

SPIFE URINE IFE is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Helena Laboratories. The 510(k) number is K982639.

When did SPIFE URINE IFE receive FDA 510(k) clearance?

SPIFE URINE IFE received FDA 510(k) clearance on 1998-11-04, under 510(k) number K982639.

Who is the listed applicant for SPIFE URINE IFE?

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 SPIFE URINE IFE?

The FDA product code for SPIFE URINE IFE is DAO.

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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: DAO)

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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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