FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BIODEX ACT-O-KIT TSH-RIA-
K Number: K840088
·
Decision May 7, 1984
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
20
Review Days
118
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Basic Information
- Device Name
- BIODEX ACT-O-KIT TSH-RIA-
- K Number
- K840088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodan Medical Systems, Ltd.
- Date Received
- January 10, 1984
- Decision Date
- May 7, 1984
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Biodan Medical Systems, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Sep 7, 1993 | Substantially Equivalent |
| K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 | May 26, 1993 | Substantially Equivalent |
| K930262 | TREATMENT TABLE, MODEL #825-100 | Mar 29, 1993 | Substantially Equivalent |
| K930259 | TRACTION TABLE MODEL #825-200 | Mar 24, 1993 | Substantially Equivalent |
| K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES | Feb 12, 1993 | Substantially Equivalent |
| K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT | Dec 30, 1992 | Substantially Equivalent |
| K922591 | UROLOGICAL C-ARM TABLE, MODEL #056-450 | Nov 27, 1992 | Substantially Equivalent |
| K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE | Oct 20, 1992 | Substantially Equivalent |
| K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 | Oct 20, 1992 | Substantially Equivalent |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Jul 23, 1992 | Substantially Equivalent |