FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FSH RIA KIT (125I)
K Number: K772188
·
Decision Dec 22, 1977
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
7
Applicant Total
321
Review Days
27
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Basic Information
- Device Name
- FSH RIA KIT (125I)
- K Number
- K772188
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Products Corp.
- Date Received
- November 25, 1977
- Decision Date
- December 22, 1977
- Product Code
- FSH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| FSH | Tray, Surgical, Needle | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSH), ordered by most recent decision date.
S 4 INSTRUMENT STAND
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S 21 INSTRUMENT STAND
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SKINNY CHIBA NEEDLE & TRAY
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BIOPSY NEEDLES & TRAYS
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PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
FDA 510(k)
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·General, Plastic Surgery
Other Clearances by Diagnostic Products Corp.
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|---|---|---|---|
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Dec 5, 2006 | Substantially Equivalent |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Jan 21, 2004 | Substantially Equivalent |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Dec 12, 2003 | Substantially Equivalent |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Oct 10, 2003 | Substantially Equivalent |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | Dec 17, 2002 | Substantially Equivalent |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Dec 9, 2002 | Substantially Equivalent |
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Aug 21, 2002 | Substantially Equivalent |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Jun 3, 2002 | Substantially Equivalent |
| K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS | May 30, 2002 | Substantially Equivalent |