FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K Number: K000116
·
Decision Feb 15, 2000
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
20
Review Days
32
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Basic Information
- Device Name
- QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
- K Number
- K000116
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Consolidated Technologies, Inc.
- Date Received
- January 14, 2000
- Decision Date
- February 15, 2000
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Consolidated Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | Sep 3, 1999 | Substantially Equivalent |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | Sep 3, 1999 | Substantially Equivalent |
| K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | Jul 14, 1999 | Substantially Equivalent |
| K981339 | QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3 | Apr 21, 1998 | Substantially Equivalent |
| K974699 | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE | Jan 22, 1998 | Substantially Equivalent |
| K973469 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS | Sep 25, 1997 | Substantially Equivalent |
| K972146 | QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS | Jul 8, 1997 | Substantially Equivalent |
| K972080 | QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 | Jun 18, 1997 | Substantially Equivalent |
| K961815 | QUALITROL ANA CONTROL SERUM SET | Sep 27, 1996 | Substantially Equivalent |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Sep 24, 1996 | Substantially Equivalent |