FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
K Number: K080136
·
Decision Aug 15, 2008
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
12
Review Days
206
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Basic Information
- Device Name
- INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
- K Number
- K080136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Steritec Products, Inc.
- Date Received
- January 22, 2008
- Decision Date
- August 15, 2008
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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Other Clearances by Steritec Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083650 | EMU-GRAPH 4 EMULATOR, MODEL CI 144 | Mar 5, 2009 | Substantially Equivalent |
| K052516 | STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 | Oct 3, 2005 | Substantially Equivalent |
| K040901 | STERITEC EMU-GRAPH, MODEL NO. CI 131/US | Sep 9, 2004 | Substantially Equivalent |
| K024293 | BOWIE-DICK MINI PAK, MODEL BD 115 | Aug 11, 2003 | Substantially Equivalent |
| K012732 | INTEGRAPH FLASH, MODEL CI 110 | Mar 4, 2002 | Substantially Equivalent |
| K010534 | CROSS-CHECKS DUAL, MODEL CI 125 | Aug 6, 2001 | Substantially Equivalent |
| K003533 | CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L | Feb 7, 2001 | Substantially Equivalent |
| K003002 | STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 | Dec 8, 2000 | Substantially Equivalent |
| K002861 | EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 | Nov 29, 2000 | Substantially Equivalent |
| K001649 | STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 | Jun 23, 2000 | Substantially Equivalent |