Identity
- Trade Name
- ProtoFluor Z (220V) FDA UDI
- Generic Name
- Ultraviolet-visible spectrophotometer IVD FDA UDI
- Model / Reference
- 2006000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52520060000 FDA UDI
- 510(k) Number
- K893038 FDA UDI
- FDA Product Code
- JKJ FDA UDI
- GMDN Term
- Ultraviolet-visible spectrophotometer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1595 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultraviolet-visible spectrophotometer IVD
ProtoFluor Z (220V) by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultraviolet-visible spectrophotometer IVD.
- ProtoFluor Z (110V) — Helena Laboratories, Corp. · Class I
- ProtoFluor Z (110V) — Helena Laboratories, Corp. · Class I
Cleared under the same submission
K893038 also covers:
- ProtoFluor Calibrator - High (5 x 2.5 mL) — Helena Laboratories, Corp.
- ProtoFluor Calibrator - Low (5 x 2.5 mL) — Helena Laboratories, Corp.
- ProtoFluor Glass Slides — Helena Laboratories, Corp.
- ProtoFluor Reagent (2x15 mL) — Helena Laboratories, Corp.
- ProtoFluor Reagent System (Part 1 of 2) — Helena Laboratories, Corp.
- ProtoFluor Reagent System (Part 2 of 2) — Helena Laboratories, Corp.
- ProtoFluor Z (110V) — Helena Laboratories, Corp.
- ProtoFluor Z (110V) — Helena Laboratories, Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 054aafdd-c83b-46ae-9070-66618b3fdf9e 34 fields · synced Jun 9, 2026