GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104— 510(k) K895528
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K895528 for GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104, Substantially Equivalent on 1989-10-25. 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
- Beaumont, TX, 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 →
Recalls naming K895528
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K895528.
Data sourced from openFDA. This site is unofficial and independent of the FDA.