FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSH RIA
K Number: K833910
·
Decision Nov 22, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
115
Applicant Total
31
Review Days
8
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Basic Information
- Device Name
- TSH RIA
- K Number
- K833910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3880
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Syncor Intl. Corp.
- Date Received
- November 14, 1983
- Decision Date
- November 22, 1983
- Product Code
- ETD
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| ETD | Tube, Tympanostomy | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ETD), ordered by most recent decision date.
Tula Tympanostomy Tube Delivery Device
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Solo+ Tympanostomy Tube Device (TTD)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Biowy Tym Tube (TT)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Tympanostomy Tubes
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hummingbird Tympanostomy Tube System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Syncor Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945825 | SECURE SAFETY INSERT | Apr 10, 1995 | Substantially Equivalent |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Sep 19, 1985 | Substantially Equivalent |
| K850433 | CESIUM 137 ENDOMETRIAL SOURCE | Aug 21, 1985 | Substantially Equivalent |
| K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 | Aug 21, 1985 | Substantially Equivalent |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | Aug 13, 1985 | Substantially Equivalent |
| K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT | Jun 21, 1985 | Substantially Equivalent |
| K844735 | PTH-RIA | Apr 29, 1985 | Substantially Equivalent |
| K850163 | IRIDIUM 192 WIRES | Mar 26, 1985 | Substantially Equivalent |
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Mar 26, 1985 | Substantially Equivalent |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Mar 26, 1985 | Substantially Equivalent |