HELENA COLOCARE— 510(k) K882799
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K882799 for HELENA COLOCARE, Substantially Equivalent on 1988-09-30. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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Recalls naming K882799
K-number listed on FDA's recall record- Z-1949-2019 — ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Z-1950-2019 — ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K882799.
Data sourced from openFDA. This site is unofficial and independent of the FDA.