FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVK CONTROL I & II
K Number: K921665
·
Decision Jun 9, 1992
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
79
Review Days
63
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Basic Information
- Device Name
- AVK CONTROL I & II
- K Number
- K921665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Bioproducts Co.
- Date Received
- April 7, 1992
- Decision Date
- June 9, 1992
- Product Code
- GGC
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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Other Clearances by American Bioproducts Co.
| K Number | Device Name | ||
|---|---|---|---|
| K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | Nov 12, 1998 | Substantially Equivalent |
| K971519 | ASSERACHROM TPA TEST KIT | Aug 19, 1997 | Substantially Equivalent |
| K964716 | STA LIATEST CONTROL [N]+[P] KIT | Jun 26, 1997 | Substantially Equivalent |
| K964728 | STA-LIATEST D-DI TEST KIT | Jun 26, 1997 | Substantially Equivalent |
| K964718 | STA D-DI CALIBRATOR KIT | May 23, 1997 | Substantially Equivalent |
| K962675 | STA - LIATEST VWF TEST KIT | Oct 25, 1996 | Substantially Equivalent |
| K962671 | STA-VWF CALIBRATOR KIT | Sep 13, 1996 | Substantially Equivalent |
| K962674 | STA - VWF CONTROL [N]+[P] KIT | Jul 23, 1996 | Substantially Equivalent |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | Jul 10, 1996 | Substantially Equivalent |
| K955040 | AT-III CONTROL PLASMA KIT | Jan 31, 1996 | Substantially Equivalent |