GREINER VACUETTE BLOOD COLLECTION TUBE— 510(k) K971221
Substantially EquivalentGreiner America, Inc.
FDA 510(k) clearance K971221 for GREINER VACUETTE BLOOD COLLECTION TUBE, Substantially Equivalent on 1997-05-02. Applicant: Greiner America, Inc.. Device class: 2.
Clearance details
- Applicant
- Greiner America, Inc.
- Product code
- Code GIM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Mary, FL, US
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More clearances from Greiner America, Inc.
view allAdverse events under product code GIM
product code GIM- Malfunction
- 1,325
- Total
- 1,325
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 K971221
K-number listed on FDA's recall record- Z-0408-2026 — Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
- Z-2507-2021 — Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
- Z-1534-2021 — VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
- Z-1714-2020 — VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
- Z-2154-2012 — 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971221.
Data sourced from openFDA. This site is unofficial and independent of the FDA.