FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K Number: K881693
·
Decision Jun 7, 1988
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
143
Review Days
49
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Basic Information
- Device Name
- TERUMO SENSIBEAD EIA PROGESTERONE KIT
- K Number
- K881693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Terumo Medical Corp.
- Date Received
- April 19, 1988
- Decision Date
- June 7, 1988
- Product Code
- JIS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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Other Clearances by Terumo Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Oct 3, 2011 | Substantially Equivalent |
| K111556 | GLIDECROSS SUPPORT CATHETER | Jul 29, 2011 | Substantially Equivalent |
| K110540 | TERUMO SUPPORT CATHETER | May 13, 2011 | Substantially Equivalent |
| K102008 | GLIDESHEATH | Jul 21, 2010 | Substantially Equivalent |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 29, 2009 | Substantially Equivalent |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Apr 15, 2009 | Substantially Equivalent |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Feb 6, 2009 | Substantially Equivalent |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Oct 29, 2008 | Substantially Equivalent |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Sep 26, 2008 | Substantially Equivalent |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Sep 24, 2008 | Substantially Equivalent |