FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K Number: K874094
·
Decision Nov 4, 1987
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
52
Review Days
35
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Basic Information
- Device Name
- 1205 BETAPLATE LIQUID SCINTILLATION COUNTER
- K Number
- K874094
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Lkb Instruments, Inc.
- Date Received
- September 30, 1987
- Decision Date
- November 4, 1987
- Product Code
- JJJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Lkb Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K862044 | DELFIA (TM) HCG KIT | Jul 11, 1986 | Substantially Equivalent |