LKB 2230 ROTARY ONE
FDA 510(k) clearance K843505 · decided 1984-11-30
Clearance details
- K-number
- K843505
- Device name
- LKB 2230 ROTARY ONE
- Applicant
- Lkb Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-06
- Decision date
- 1984-11-30
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- IDO
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Gaithersburg, MD, 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 |
|---|---|---|
| LKB 2260 MACROTOME (K864733) | Lkb Instruments, Inc. | 1987-01-05 |
| ROTARY MICROTOME (K863548) | Surgipath Medical Industries, Inc. | 1986-09-19 |
| TISSUE-TEK III ACCU-CUT ROTARY MICROTOME (K812558) | Miles Laboratories, Inc. | 1981-09-29 |
| LKB-BROMMA 2218 HISTORANGE MICROTOME (K812157) | Lkb Instruments, Inc. | 1981-08-18 |
Recalls involving this device
No recalls on record reference this clearance.