510(k) K802818
- Device
- PULLEN POCKET SCOPE
- Applicant
- P.A. RESEARCH CORP.
- 510(k) number
- K802818
- Product code
- IBJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-04-17
- Date received
- 1980-11-07
- Regulation
- 864.3600
- Classification name
- Light, Microscope
- Medical specialty
- Pathology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006610913
- 3015505238
- 3007123908
- 3004468424
- 3006580954
- 9615162
- 3005527296
- 3033524688
- 3009391651
- 3021959405
- 3003825930
- 3013660430
- 3027645317
- 3043009938
- 9615060
- 3027605723
- 3011707917
- 3012476694
- 3014683120
- 3043088937
- 3022763794
- 3016446653
- 3033524192
- 1927430
- 1054713
- 3008564898
- 3003969012
- 3001111904
- 3021720733
- 3043138885
- 1067123
- 2249760
- 9614084
- 8010666
- 3010399828
- 3020305854
- 3006973688
- 3009560832
- 3021967177
- 3008624479
- 3013395426
- 1648557
- 2434008
- 2083544
- 3010420046
- 3003893952
- 3010367859
- 3032109
- 3005944680
- 3008262355
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IBJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874750 | VIDEO ANALYZER 4000 | Scientific Imaging, Inc. | 1988-04-25 |
| K874190 | CELL COUNTING GRID GRATICULE | Portable Medical Laboratories, Inc. | 1988-01-05 |
| K874207 | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION | Intl. Remote Imaging Systems | 1988-01-05 |
| K864049 | MCARTHUR MICROSCOPE, STANDARD METAL VERSION | Portable Medical Laboratories, Inc. | 1986-10-29 |
| K854735 | MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. | Portable Medical Laboratories, Inc. | 1985-12-10 |
| K823040 | PATHOLOGY INSTRUMENTATION & ACCESSORIES | Iris Remote Imaging Systems | 1983-01-14 |
| K822207 | 2XC MICROSCOPE | Amarel Precision Instruments, Inc. | 1982-08-05 |
| K821865 | A O MICROSCOPE VIDEO SYSTEM | Warner-Lambert Co. | 1982-07-14 |
Legacy Summary#
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FDA Review#
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