FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RF CONTROLS
K Number: K790986
·
Decision Jun 28, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
34
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Basic Information
- Device Name
- RF CONTROLS
- K Number
- K790986
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Wampole Laboratories
- Date Received
- May 25, 1979
- Decision Date
- June 28, 1979
- Product Code
- DMR
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DMR | Solution, M-Nitrophenol, Specific Reagent For Cholinesterase | FDA class 1 | Clinical Toxicology |
Other Clearances by Wampole Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K965131 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Mar 26, 1997 | Substantially Equivalent |
| K965129 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Mar 26, 1997 | Substantially Equivalent |
| K911444 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM | Aug 30, 1991 | Substantially Equivalent |
| K882896 | ONE-STEP HCG | Oct 31, 1988 | Substantially Equivalent |
| K883004 | MONO-PLUS(TM) | Aug 4, 1988 | Substantially Equivalent |
| K875101 | VIROGEN CMV ANTIBODY TEST | Mar 1, 1988 | Substantially Equivalent |
| K875161 | MAT (TM) MICROALBUMIN TEST | Feb 17, 1988 | Substantially Equivalent |
| K791309 | UCG-LYPHOTEST | Jul 30, 1979 | Substantially Equivalent |
| K781794 | BETA-TEC | Dec 29, 1978 | Substantially Equivalent |
| K760336 | BIOCEPT-G | Nov 12, 1976 | Substantially Equivalent |