WESCOR MODEL 7300 AEROSPRAY GRAM STAINER— 510(k) K881592
Substantially EquivalentWescor, Inc.
FDA 510(k) clearance K881592 for WESCOR MODEL 7300 AEROSPRAY GRAM STAINER, Substantially Equivalent on 1988-05-13. Applicant: Wescor, Inc.. Device class: 1.
Clearance details
- Applicant
- Wescor, Inc.
- Product code
- Code KPA
- Device class
- Class 1
- Regulation
- 21 CFR 864.3800
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Logan, UT, US
Recent devices under product code KPA
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view all- K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
- K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
- K863395 — WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
- K881512 — WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
- K880544 — WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
Adverse events under product code KPA
product code KPA- Malfunction
- 1,177
- Total
- 1,177
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.