PATHOLOGY INSTRUMENTATION & ACCESSORIES
FDA 510(k) clearance K823040 · decided 1983-01-14
Clearance details
- K-number
- K823040
- Device name
- PATHOLOGY INSTRUMENTATION & ACCESSORIES
- Applicant
- Iris Remote Imaging Systems
- Decision
- Substantially Equivalent
- Date received
- 1982-10-14
- Decision date
- 1983-01-14
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- IBJ
- Device class
- 1
- Regulation number
- 864.3600
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIDEO ANALYZER 4000 (K874750) | Scientific Imaging, Inc. | 1988-04-25 |
| THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (K874207) | Intl. Remote Imaging Systems | 1988-01-05 |
| CELL COUNTING GRID GRATICULE (K874190) | Portable Medical Laboratories, Inc. | 1988-01-05 |
| MCARTHUR MICROSCOPE, STANDARD METAL VERSION (K864049) | Portable Medical Laboratories, Inc. | 1986-10-29 |
| MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (K854735) | Portable Medical Laboratories, Inc. | 1985-12-10 |
| 2XC MICROSCOPE (K822207) | Amarel Precision Instruments, Inc. | 1982-08-05 |
| A O MICROSCOPE VIDEO SYSTEM (K821865) | Warner-Lambert Co. | 1982-07-14 |
| PULLEN POCKET SCOPE (K802818) | P.A. Research Corp. | 1981-04-17 |
Recalls involving this device
No recalls on record reference this clearance.