QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS— 510(k) K972146
Substantially EquivalentConsolidated Technologies, Inc.
FDA 510(k) clearance K972146 for QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS, Substantially Equivalent on 1997-07-08. Applicant: Consolidated Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Consolidated Technologies, Inc.
- Product code
- Code LYR
- Device class
- Class 1
- Regulation
- 21 CFR 866.3110
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code LYR
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- K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
- K981339 — QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
Adverse events under product code LYR
product code LYR- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.