FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B-GCG SYSTEM BY RIA
K Number: K830526
·
Decision Apr 5, 1983
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
29
Review Days
47
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Basic Information
- Device Name
- B-GCG SYSTEM BY RIA
- K Number
- K830526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pcl-Ria, Inc.
- Date Received
- February 17, 1983
- Decision Date
- April 5, 1983
- Product Code
- JHI
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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Other Clearances by Pcl-Ria, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K822935 | THYROID STIMULATING HORMONE | Nov 1, 1982 | Substantially Equivalent |
| K823014 | DIGOXIN KIT | Nov 1, 1982 | Substantially Equivalent |
| K822612 | T3 UPTAKE KITS | Sep 30, 1982 | Substantially Equivalent |
| K820886 | THYROXINE T4 KIT | Apr 16, 1982 | Substantially Equivalent |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | Mar 26, 1982 | Substantially Equivalent |
| K820357 | LUTEINIZING HORMONE KIT | Mar 25, 1982 | Substantially Equivalent |
| K812666 | THYROXINE (T4) 125I | Oct 2, 1981 | Substantially Equivalent |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | Apr 14, 1981 | Substantially Equivalent |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | Apr 8, 1981 | Substantially Equivalent |
| K810754 | LUTENIZING HORMONES | Mar 31, 1981 | Substantially Equivalent |