FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BCG REAGENT SERUM ALBUMIN W/TECHNICON
K Number: K802157
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
16
Review Days
32
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Basic Information
- Device Name
- BCG REAGENT SERUM ALBUMIN W/TECHNICON
- K Number
- K802157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Panmed, Inc.
- Date Received
- September 8, 1980
- Decision Date
- October 10, 1980
- Product Code
- CIX
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Panmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852767 | ERYTHOCYTE CREATINE | Nov 13, 1986 | Substantially Equivalent |
| K820642 | SICKLE-CHECK | Apr 14, 1982 | Substantially Equivalent |
| K802155 | REAGENTS SERUM SODIUM USING THE TECH. | Oct 10, 1980 | Substantially Equivalent |
| K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION | Oct 10, 1980 | Substantially Equivalent |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802156 | REAGENTS SERUM CREATINE USING TECHICON | Oct 10, 1980 | Substantially Equivalent |
| K802163 | CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802159 | AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS | Oct 10, 1980 | Substantially Equivalent |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Oct 10, 1980 | Substantially Equivalent |
| K802164 | 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. | Oct 10, 1980 | Substantially Equivalent |