510(k) K812158
- Device
- LKB-BROMMA 2188 ULTROTOME NOVA
- Applicant
- LKB INSTRUMENTS, INC.
- 510(k) number
- K812158
- Product code
- IDM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-16
- Date received
- 1981-07-29
- Regulation
- 864.3010
- Classification name
- Microtome, Ultra
- Medical specialty
- Pathology
- Review panel
- Hematology
- 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#
- 3010194621
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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