CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
FDA 510(k) clearance K921465 · decided 1992-06-29
Clearance details
- K-number
- K921465
- Device name
- CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1992-03-27
- Decision date
- 1992-06-29
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- GKP
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Helena Laboratories
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) (K242127) | Instrumentation Laboratory (IL) Co. | 2024-08-16 |
| ACL TOP Family 70 Series (K231031) | Instrumentation Laboratory Company | 2023-06-21 |
| ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) (K160276) | Instrumentation Laboratory CO | 2016-03-03 |
| ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS (K150877) | Instrumentation Laboratory CO | 2015-12-13 |
| ACL TOP 700 LAS (K091980) | Instrumentation Laboratory CO | 2009-09-22 |
| ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (K073377) | Instrumentation Laboratory CO | 2008-05-04 |
| ACL TOP (K063679) | Instrumentation Laboratory CO | 2007-01-12 |
| ACL TOP MODEL, TOP (K033414) | Instrumentation Laboratory CO | 2004-01-12 |
| SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 (K031377) | Dade Behring, Inc. | 2003-09-08 |
| FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN (K023362) | Fisher Diagnostics | 2002-12-09 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 (K020979) | Dade Behring, Inc. | 2002-06-27 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K001645) | Dade Behring, Inc. | 2000-08-04 |
Recalls involving this device
No recalls on record reference this clearance.