FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GC BASE W/ 1% GCHI
K Number: K954986
·
Decision Feb 16, 1996
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
82
Applicant Total
10
Review Days
108
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Basic Information
- Device Name
- GC BASE W/ 1% GCHI
- K Number
- K954986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2410
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Remel, L.P.
- Date Received
- October 31, 1995
- Decision Date
- February 16, 1996
- Product Code
- JTY
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | FDA class 2 | Microbiology |
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Other Clearances by Remel, L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | Aug 28, 1997 | Substantially Equivalent |
| K964315 | REMEL STAPH LATEX KIT | Feb 7, 1997 | Substantially Equivalent |
| K964421 | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK | Dec 6, 1996 | Substantially Equivalent |
| K961046 | 10B ARGININE BROTH | Sep 18, 1996 | Substantially Equivalent |
| K955143 | RPR LIQUID CONTROLS | Jul 30, 1996 | Substantially Equivalent |
| K955136 | RPR CARD TEST KIT | Jul 29, 1996 | Substantially Equivalent |
| K961818 | GENTAMICIN DISK (120MCG) | Jul 10, 1996 | Substantially Equivalent |
| K961819 | STREPTOMYCIN DISK (300MCG) | Jul 10, 1996 | Substantially Equivalent |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | Mar 25, 1996 | Substantially Equivalent |