510(k) K843505
- Device
- LKB 2230 ROTARY ONE
- Applicant
- LKB INSTRUMENTS, INC.
- 510(k) number
- K843505
- Product code
- IDO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-30
- Date received
- 1984-09-06
- Regulation
- 864.3010
- Classification name
- Microtome, Rotary
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ED ZIOR
- Address
- 9319 Gaither Rd. Gaithersburg MD US 20877 20877
FDA Registration Numbers#
- 3010685493
- 2083544
- 3006610913
- 3010889707
- 3018771894
- 3023034117
- 3010781643
- 8010478
- 3014165737
- 3003584784
- 1000391282
- 3008399755
- 1063851
- 3013666218
- 9613910
- 9614585
- 3009963993
- 3010194621
- 3033165977
- 3005642384
- 3016764932
- 3043606682
- 3021013124
- 3010692993
- 3015167933
- 3004594181
- 3009155756
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IDO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864733 | LKB 2260 MACROTOME | Lkb Instruments, Inc. | 1987-01-05 |
| K863548 | ROTARY MICROTOME | Surgipath Medical Industries, Inc. | 1986-09-19 |
| K812558 | TISSUE-TEK III ACCU-CUT ROTARY MICROTOME | Miles Laboratories, Inc. | 1981-09-29 |
| K812157 | LKB-BROMMA 2218 HISTORANGE MICROTOME | Lkb Instruments, Inc. | 1981-08-18 |
Legacy Summary#
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FDA Review#
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