ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F— 510(k) K993388
Substantially EquivalentPharmacia & Upjohn Co.
FDA 510(k) clearance K993388 for ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F, Substantially Equivalent on 1999-12-01. Applicant: Pharmacia & Upjohn Co.. Device class: 2.
Clearance details
- Applicant
- Pharmacia & Upjohn Co.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westervillle, OH, US
Recent devices under product code DHB
view allMore clearances from Pharmacia & Upjohn Co.
view all- K003414 — VARELISA TG (THYROGLOBULIN) ANTIBODIES,
- K002556 — CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
- K000312 — VARELISA SM ANTIBODIES
- K000132 — ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
- K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396
Recalls naming K993388
K-number listed on FDA's recall record- Z-1312-2018 — ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
- Z-1313-2018 — ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993388.
Data sourced from openFDA. This site is unofficial and independent of the FDA.