FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DELFIA (TM) HUMAN PROLACTIN
K Number: K861542
·
Decision Jun 17, 1986
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
52
Review Days
54
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Basic Information
- Device Name
- DELFIA (TM) HUMAN PROLACTIN
- K Number
- K861542
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Lkb Instruments, Inc.
- Date Received
- April 24, 1986
- Decision Date
- June 17, 1986
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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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 |