LIQUID LDH-L REAGENT SET— 510(k) K973589
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K973589 for LIQUID LDH-L REAGENT SET, Substantially Equivalent on 1997-10-08. Applicant: Pointe Scientific, Inc.,. Device class: 2.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
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- K970684 — LACTATE DEHYDROGENASE (LD)
More clearances from Pointe Scientific, Inc.,
view allRecalls naming K973589
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 K973589.
Data sourced from openFDA. This site is unofficial and independent of the FDA.