FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTRA REAGENT CONCENTRATE SYSTEM
K Number: K812866
·
Decision Dec 17, 1981
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
23
Review Days
65
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Basic Information
- Device Name
- ASTRA REAGENT CONCENTRATE SYSTEM
- K Number
- K812866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nobel Scientific Industries, Inc.
- Date Received
- October 13, 1981
- Decision Date
- December 17, 1981
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Nobel Scientific Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854717 | NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 | Jan 14, 1986 | Substantially Equivalent |
| K854716 | NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 | Jan 7, 1986 | Substantially Equivalent |
| K854718 | NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 | Dec 19, 1985 | Substantially Equivalent |
| K850944 | NSI LYSING-D REAGENT -4000 ML | Mar 29, 1985 | Substantially Equivalent |
| K844782 | NSI ELT-D DILUTING FLUID 4000ML | Mar 5, 1985 | Substantially Equivalent |
| K823283 | FLUSHING SOLUTION | Dec 3, 1982 | Substantially Equivalent |
| K810549 | THERMAL PRINTER PAPER | Apr 8, 1981 | Substantially Equivalent |
| K810550 | SILVER ANODE | Apr 8, 1981 | Substantially Equivalent |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nov 12, 1980 | Substantially Equivalent |
| K801346 | NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA | Aug 12, 1980 | Substantially Equivalent |