FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ASSERA-PLATE PROTEIN S KIT
K Number: K870042
·
Decision Feb 13, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
79
Review Days
39
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Basic Information
- Device Name
- ASSERA-PLATE PROTEIN S KIT
- K Number
- K870042
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- American Bioproducts Co.
- Date Received
- January 5, 1987
- Decision Date
- February 13, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- HE
- Third Party
- N
Other Clearances by American Bioproducts Co.
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|---|---|---|---|
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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 |