FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASSERACHROM IX:AG
K Number: K854312
·
Decision Feb 4, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
79
Review Days
99
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Basic Information
- Device Name
- ASSERACHROM IX:AG
- K Number
- K854312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- American Bioproducts Co.
- Date Received
- October 28, 1985
- Decision Date
- February 4, 1986
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by American Bioproducts Co.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |