FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K Number: K852192
·
Decision Nov 1, 1985
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
47
Review Days
165
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Basic Information
- Device Name
- DISPOSABLE STEAM BIOLOGICAL TEST PACK
- K Number
- K852192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Parke-Davis Co.
- Date Received
- May 20, 1985
- Decision Date
- November 1, 1985
- Product Code
- FRC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by Parke-Davis Co.
| K Number | Device Name | ||
|---|---|---|---|
| K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT | Dec 4, 1986 | Substantially Equivalent |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | Aug 29, 1986 | Substantially Equivalent |
| K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK | Jun 18, 1986 | Substantially Equivalent |
| K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE | Mar 31, 1986 | Substantially Equivalent |
| K860290 | VIAPIC CENTRAL LINE CATHETER | Mar 18, 1986 | Substantially Equivalent |
| K841967 | DESERET THERMODILUTION CARDIAC OUTPUT | Aug 19, 1985 | Substantially Equivalent |
| K851327 | DESERET ARTERIAL CATHETER | Jun 14, 1985 | Substantially Equivalent |
| K852078 | SPECTRUM(TENTATIVE) | Jun 7, 1985 | Substantially Equivalent |
| K844840 | DESERET INTRODUCER SET | May 16, 1985 | Substantially Equivalent |
| K850505 | DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER | Mar 11, 1985 | Substantially Equivalent |