FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
K Number: K143075
·
Decision Jul 2, 2015
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
20
Review Days
248
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Basic Information
- Device Name
- ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
- K Number
- K143075
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tosoh Bioscience, Inc.
- Date Received
- October 27, 2014
- Decision Date
- July 2, 2015
- Product Code
- CDZ
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Tosoh Bioscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K160113 | ST AIA-PACK hsE2 Calibrator Set | Feb 17, 2016 | Substantially Equivalent |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Dec 18, 2015 | Substantially Equivalent |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set | Oct 26, 2015 | Substantially Equivalent |
| K143296 | AIA-PACK C-Peptide Control Set | Dec 16, 2014 | Substantially Equivalent |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Dec 3, 2014 | Substantially Equivalent |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | Apr 10, 2014 | Substantially Equivalent |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | Jan 23, 2014 | Substantially Equivalent |