FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LKB 2230 ROTARY ONE
K Number: K843505
·
Decision Nov 30, 1984
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
4
Applicant Total
52
Review Days
85
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Basic Information
- Device Name
- LKB 2230 ROTARY ONE
- K Number
- K843505
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Lkb Instruments, Inc.
- Date Received
- September 6, 1984
- Decision Date
- November 30, 1984
- Product Code
- IDO
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IDO | Microtome, Rotary | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IDO), ordered by most recent decision date.
LKB 2260 MACROTOME
FDA 510(k)
FDA Class 1
·Pathology
ROTARY MICROTOME
FDA 510(k)
FDA Class 1
·Pathology
TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
FDA 510(k)
FDA Class 1
·Pathology
LKB-BROMMA 2218 HISTORANGE MICROTOME
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by Lkb Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Nov 4, 1987 | Substantially Equivalent |
| K872955 | DELFIA(TM) FERRITIN KIT | Aug 21, 1987 | Substantially Equivalent |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | Jun 17, 1987 | Substantially Equivalent |
| K871599 | DELFIA(TM) HIGE KIT | Jun 12, 1987 | Substantially Equivalent |
| K871644 | DELFIA (TM) HTSH KIT | May 12, 1987 | Substantially Equivalent |
| K864452 | DELFIA(TM) TRIIODOTHYRONINE (T3) KIT | Feb 2, 1987 | Substantially Equivalent |
| K864733 | LKB 2260 MACROTOME | Jan 5, 1987 | Substantially Equivalent |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | Dec 18, 1986 | Substantially Equivalent |
| K863422 | DELFIA(TM) CORTISOL KIT | Sep 26, 1986 | Substantially Equivalent |
| K861195 | DELFIA DIGOXIN | Jul 11, 1986 | Substantially Equivalent |