510(k) K841785
- Device
- RADCAL MODEL 4046 RADIONUCLIDE CALIBR
- Applicant
- RADCAL CORP.
- 510(k) number
- K841785
- Product code
- KPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-07-16
- Date received
- 1984-04-30
- Regulation
- 892.1360
- Classification name
- Calibrator, Dose, Radionuclide
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009694288
- 2518443
Source Documents#
510(k) summary PDF not indicated by FDA
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| K020150 | CRC-15BT | Capintec, Inc. | 2002-08-02 |
| K013689 | RE-ENTRANT CHAMBER | Sun Nuclear Corp. | 2002-07-02 |
| K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER | Standard Imaging, Inc. | 2001-11-09 |
| K010417 | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | Nuclear Assoc., Div. Inovision LP | 2001-04-26 |
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Legacy Summary#
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FDA Review#
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