FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
K Number: K962664
·
Decision Sep 10, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
17
Review Days
63
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
- K Number
- K962664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Laboratory Automation Systems, Inc.
- Date Received
- July 9, 1996
- Decision Date
- September 10, 1996
- Product Code
- GKP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKP), ordered by most recent decision 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)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP Family 70 Series
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 700 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Medical Laboratory Automation Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944227 | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER | Feb 3, 1995 | Substantially Equivalent |
| K931206 | ELECTRA 1600C AUTOMATIC COAGULATION TIMER | Aug 23, 1993 | Substantially Equivalent |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Sep 29, 1992 | Substantially Equivalent |
| K903638 | GASTRO-INTESTINAL ACCU-CULSHURE TM | Jan 18, 1991 | Substantially Equivalent |
| K903405 | CHLAMYDIA ACCU-CULSHURE TM | Oct 16, 1990 | Substantially Equivalent |
| K903406 | VIRAL ACCU-CULSHURE TM | Oct 16, 1990 | Substantially Equivalent |
| K901645 | ANAEROBIC ACCU-CULSHURE(TM) | Jul 16, 1990 | Substantially Equivalent |
| K894052 | ELECTRA 1000C AUTOMATIC COAGULATION TIMER | Jul 27, 1989 | Substantially Equivalent |
| K884863 | ELECTRA 900C AUTOMATIC COAGULATION TIMER | Feb 3, 1989 | Substantially Equivalent |
| K871687 | TYTEM(R) REAGENT DISPENSER | May 20, 1987 | Substantially Equivalent |