FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
K Number: K954968
·
Decision Jul 26, 1996
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
14
Review Days
273
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Basic Information
- Device Name
- HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
- K Number
- K954968
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tcpi, Inc.
- Date Received
- October 27, 1995
- Decision Date
- July 26, 1996
- Product Code
- JIL
- 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
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Other Clearances by Tcpi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981363 | ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST | Dec 22, 1998 | Substantially Equivalent |
| K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE | Oct 7, 1998 | Substantially Equivalent |
| K981197 | ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST | Jun 16, 1998 | Substantially Equivalent |
| K980776 | ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST | Apr 29, 1998 | Substantially Equivalent |
| K951853 | ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) | Aug 20, 1996 | Substantially Equivalent |
| K954685 | URITEST - NITRITE IN URINE TEST | Jul 22, 1996 | Substantially Equivalent |
| K955353 | ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT | Mar 19, 1996 | Substantially Equivalent |
| K951892 | ONE STEP URINE DRUG OF ABUSE COCAINE TEST | Aug 17, 1995 | Substantially Equivalent |
| K952096 | ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) | Aug 17, 1995 | Substantially Equivalent |
| K941765 | HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE | Oct 20, 1994 | Substantially Equivalent |