HEPARIN CONTROL PLASMA
FDA 510(k) clearance K760918 · decided 1977-01-10
Clearance details
- K-number
- K760918
- Device name
- HEPARIN CONTROL PLASMA
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1976-10-28
- Decision date
- 1977-01-10
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- GFO
- Device class
- 2
- Regulation number
- 864.7925
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hyland Therapeutic Div.
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 |
|---|---|---|
| HemosIL Silica Clotting Time (K253957) | Instrumentation Laboratory (IL) Co. | 2026-01-09 |
| Cryocheck Hex LA (K193556) | Precision Biologic | 2020-10-23 |
| HemosIL Silica Clotting Time (K160445) | Instrumentation Laboratory CO | 2016-03-16 |
| STA-CEPHASCREEN KIT (K053111) | Diagnostica Stago, Inc. | 2006-05-04 |
| HEMOSIL SYNTHASIL (K060688) | Instrumentation Laboratory CO | 2006-04-13 |
| HEMOSIL SILICA CLOTTING TIME (K050221) | Instrumentation Laboratory CO | 2005-03-30 |
| VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (K022021) | Vital Scientific N.V. | 2002-11-01 |
| CARESIDE APTT (K014028) | Careside Hemotology, Inc. | 2002-02-08 |
| HEMOCHRON JR. CITRATE APTT CUVETTE (K014008) | Itc, Inc. | 2002-01-24 |
| SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (K992712) | Sigma Diagnostics, Inc. | 1999-12-06 |
| SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 (K992711) | Sigma Diagnostics, Inc. | 1999-12-06 |
| HEMOCHRON CITRATE APTT (K972831) | International Technidyne Corp. | 1997-11-20 |
Recalls involving this device
No recalls on record reference this clearance.