FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIA-PACK CPR ASSAY
K Number: K951848
·
Decision Feb 13, 1996
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
9
Applicant Total
41
Review Days
298
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Basic Information
- Device Name
- AIA-PACK CPR ASSAY
- K Number
- K951848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1135
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tosoh Medics, Inc.
- Date Received
- April 21, 1995
- Decision Date
- February 13, 1996
- Product Code
- JKD
- 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 |
|---|---|---|---|
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKD), ordered by most recent decision date.
IMMULITE C-PEPTIDE
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DSL C-PEPTIDE RIA (DSL #7000)
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DOUBLE ANTIBODY C-PEPTIDE RIA KIT
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·Clinical Chemistry
C-PEP-RIA-100
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·Clinical Chemistry
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Tosoh Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Dec 18, 2002 | Substantially Equivalent |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Dec 17, 2002 | Substantially Equivalent |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Dec 17, 2002 | Substantially Equivalent |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | Dec 6, 2002 | Substantially Equivalent |
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | May 14, 2002 | Substantially Equivalent |
| K012820 | AIA-PACK CTNI 2ND-GEN ASSAY | Dec 14, 2001 | Substantially Equivalent |
| K011434 | G7 AUTOMATED HPLC ANALYZER | Sep 18, 2001 | Substantially Equivalent |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Aug 16, 2001 | Substantially Equivalent |
| K992365 | AIA-PACK FOLATE ASSAY | Aug 10, 1999 | Substantially Equivalent |
| K990431 | AIA-PACK CA 125 | Jun 3, 1999 | Substantially Equivalent |