FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K Number: K991480
·
Decision Sep 17, 1999
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
15
Review Days
142
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Basic Information
- Device Name
- EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
- K Number
- K991480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Selfcare, Inc.
- Date Received
- April 28, 1999
- Decision Date
- September 17, 1999
- 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 Selfcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Oct 12, 2000 | Substantially Equivalent |
| K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Aug 7, 2000 | Substantially Equivalent |
| K002049 | INVERNESS MEDICAL EARLY PREGNANCY TEST | Jul 27, 2000 | Substantially Equivalent |
| K001427 | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Jun 2, 2000 | Substantially Equivalent |
| K000583 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Mar 17, 2000 | Substantially Equivalent |
| K993632 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Nov 12, 1999 | Substantially Equivalent |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | May 25, 1999 | Substantially Equivalent |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | May 25, 1999 | Substantially Equivalent |
| K990939 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Apr 20, 1999 | Substantially Equivalent |
| K983468 | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | Dec 17, 1998 | Substantially Equivalent |