FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MLA ELECTRA 750 COAGULATION TIMER
K Number: K780810
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
179
Applicant Total
17
Review Days
27
Basic Information
- Device Name
- MLA ELECTRA 750 COAGULATION TIMER
- K Number
- K780810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
- Date Received
- May 18, 1978
- Decision Date
- June 14, 1978
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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Other Clearances by MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K962664 | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER | Sep 10, 1996 | Substantially Equivalent |
| 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 |