ACID HEMOGLOBIN KIT— 510(k) K992199
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K992199 for ACID HEMOGLOBIN KIT, Substantially Equivalent on 1999-09-21. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JBD
- Device class
- Class 2
- Regulation
- 21 CFR 864.7440
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Recent devices under product code JBD
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- K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
- K982426 — SPIFE ALKALINE HEMOGLOBIN
- K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
More clearances from Helena Laboratories
view all- K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL
- K100103 — SPECIALTY ASSAYED CONTROL-2
- K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
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