FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAG-A-MATE X2
K Number: K813564
·
Decision Jan 28, 1982
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
39
Review Days
37
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Basic Information
- Device Name
- COAG-A-MATE X2
- K Number
- K813564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- General Diagnostics
- Date Received
- December 22, 1981
- Decision Date
- January 28, 1982
- 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)
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FDA Class 2
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ACL TOP Family 70 Series
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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 General Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K882663 | BARBITURATE ENZYME IMMUNOASSAY KIT | Sep 19, 1988 | Substantially Equivalent |
| K872882 | CANNABINOID ENZYME IMMUNOASSAY KIT | Nov 3, 1987 | Substantially Equivalent |
| K871305 | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT | Jun 5, 1987 | Substantially Equivalent |
| K864993 | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE | Mar 31, 1987 | Substantially Equivalent |
| K863877 | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT | Mar 12, 1987 | Substantially Equivalent |
| K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC | Jul 20, 1984 | Substantially Equivalent |
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | Jul 2, 1984 | Substantially Equivalent |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | Dec 30, 1983 | Substantially Equivalent |
| K832653 | CEFUROXIME 30MCG. SUSCEP DISK | Oct 14, 1983 | Substantially Equivalent |
| K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP | May 9, 1983 | Substantially Equivalent |