FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMONUCLEASE AGAR W/TOLUIDINE BLUE
K Number: K864205
·
Decision Nov 24, 1986
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
137
Review Days
28
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Basic Information
- Device Name
- THERMONUCLEASE AGAR W/TOLUIDINE BLUE
- K Number
- K864205
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Remel Co.
- Date Received
- October 27, 1986
- Decision Date
- November 24, 1986
- Product Code
- JSH
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K965151 | A.C.T. III | Jan 22, 1997 | Substantially Equivalent |
| K965152 | A.C.T. II | Jan 22, 1997 | Substantially Equivalent |
| K965149 | A.C.T. I | Jan 22, 1997 | Substantially Equivalent |
| K960090 | CALCOFLUOR WHITE STAIN KIT | Mar 19, 1996 | Substantially Equivalent |
| K960095 | BACTIDROP CALCOFLUOR WHITE | Mar 19, 1996 | Substantially Equivalent |
| K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | Feb 23, 1996 | Substantially Equivalent |
| K941443 | SYNERGY QUAD | Sep 19, 1994 | Substantially Equivalent |
| K941444 | BHI AGAR WITH VANCOMYCIN | Sep 19, 1994 | Substantially Equivalent |