FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
K Number: K121533
·
Decision Jun 15, 2012
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
28
Applicant Total
20
Review Days
22
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Basic Information
- Device Name
- ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
- K Number
- K121533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1377
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tosoh Bioscience, Inc.
- Date Received
- May 24, 2012
- Decision Date
- June 15, 2012
- Product Code
- LPS
- 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 |
|---|---|---|---|
| LPS | Urinary Homocystine (Nonquantitative) Test System | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPS), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
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A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
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Other Clearances by Tosoh Bioscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Oct 3, 2025 | Substantially Equivalent |
| K211199 | ST AIA-PACK BNP Assay | Nov 8, 2021 | Substantially Equivalent |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Aug 5, 2021 | Substantially Equivalent |
| 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 |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set | Jul 2, 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 |