HELENA RISTOCETIN— 510(k) K800432
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K800432 for HELENA RISTOCETIN, Substantially Equivalent on 1980-03-25. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5700
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JOZ
view all- K191364 — T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
- K181777 — AggreGuide A-100 ADP
- K163274 — AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
- K161329 — Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
- K141427 — ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.