CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430— 510(k) K901380
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K901380 for CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430, Substantially Equivalent on 1990-05-25. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code GKP
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Recent devices under product code GKP
view all- K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
- K231031 — ACL TOP Family 70 Series
- K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
- K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- K091980 — ACL TOP 700 LAS
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.