FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K Number: K883020
·
Decision Sep 2, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
33
Review Days
45
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Basic Information
- Device Name
- RFA-300 RAPID FLOW ANALYZER W/COMPUTER
- K Number
- K883020
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Alpkem Corp.
- Date Received
- July 19, 1988
- Decision Date
- September 2, 1988
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Alpkem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K894011 | TOTAL GALACTOSE | Jan 11, 1990 | Substantially Equivalent |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Oct 27, 1989 | Substantially Equivalent |
| K890334 | TOTAL CHOLESTEROL REAGENT | May 3, 1989 | Substantially Equivalent |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Mar 9, 1989 | Substantially Equivalent |
| K890336 | GLUCOSE (GOD) REAGENT | Feb 27, 1989 | Substantially Equivalent |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Feb 17, 1989 | Substantially Equivalent |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Feb 17, 1989 | Substantially Equivalent |
| K890333 | ALBUMIN REAGENT | Feb 17, 1989 | Substantially Equivalent |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Apr 11, 1986 | Substantially Equivalent |
| K851990 | INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU | Jun 25, 1985 | Substantially Equivalent |