HELENA VMA-SMC CONTROL— 510(k) K811912
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K811912 for HELENA VMA-SMC CONTROL, Substantially Equivalent on 1981-07-23. Applicant: Helena Laboratories. Device class: 1.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JJX
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view all- K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL
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- K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
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- K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.