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FDA 510(k)

REP ALKALINE HB-15 #3196,-8 #3197,-4 3198

K-Number: K931465 · 1993-07-06

ApplicantHelena Laboratories
Decision Date1993-07-06
Product CodeJBD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1993-07-06 under 510(k) number K931465. 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 REP ALKALINE HB-15 #3196,-8 #3197,-4 3198?

REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 is a medical device that received FDA 510(k) clearance on 1993-07-06. The listed applicant is Helena Laboratories. The 510(k) number is K931465.

When did REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 receive FDA 510(k) clearance?

REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 received FDA 510(k) clearance on 1993-07-06, under 510(k) number K931465.

Who is the listed applicant for REP ALKALINE HB-15 #3196,-8 #3197,-4 3198?

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 REP ALKALINE HB-15 #3196,-8 #3197,-4 3198?

The FDA product code for REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 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)MoraxK982426SPIFE ALKALINE HEMOGLOBINHelena LaboratoriesK931503REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena 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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