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FDA 510(k)

SPIFE ALKALINE HEMOGLOBIN

K-Number: K982426 · 1998-12-17

ApplicantHelena Laboratories
Decision Date1998-12-17
Product CodeJBD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPIFE ALKALINE HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1998-12-17 under 510(k) number K982426. The device is classified under product code JBD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIFE ALKALINE HEMOGLOBIN?

SPIFE ALKALINE HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1998-12-17. The listed applicant is Helena Laboratories. The 510(k) number is K982426.

When did SPIFE ALKALINE HEMOGLOBIN receive FDA 510(k) clearance?

SPIFE ALKALINE HEMOGLOBIN received FDA 510(k) clearance on 1998-12-17, under 510(k) number K982426.

Who is the listed applicant for SPIFE ALKALINE HEMOGLOBIN?

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 ALKALINE HEMOGLOBIN?

The FDA product code for SPIFE ALKALINE HEMOGLOBIN is JBD.

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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: JBD)

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.

K053571MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K032862INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.K992199ACID HEMOGLOBIN KITHelena LaboratoriesK991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)MoraxK931503REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena LaboratoriesK931465REP ALKALINE HB-15 #3196,-8 #3197,-4 3198Helena 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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