SPIFE ALKALINE HEMOGLOBIN— 510(k) K982426

Clearance details

Applicant

Helena Laboratories

Product code

Code JBD

Device class

Class 2

Regulation

21 CFR 864.7440

Advisory panel

Hematology

Date received

1998-07-13

Decision date

1998-12-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beaumont, TX, US

• K053571 — MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM2006-06-30
• K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM2004-02-03
• K992199 — ACID HEMOGLOBIN KIT1999-09-21
• K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)1999-06-21
• K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)1993-08-16

• K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL2013-10-07
• K100103 — SPECIALTY ASSAYED CONTROL-22010-12-15
• K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA2007-02-23
• K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 34582006-07-06
• K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP2006-05-10

• Z-0297-2020 — SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systemsClass III·Ongoing·Helena Laboratories, Corp.·20180227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982426.