Anesthesiology
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- JTSStains, Microbiologic1Product Code
- K960090CALCOFLUOR WHITE STAIN KIT1Cleared 510(K)
- K960095BACTIDROP CALCOFLUOR WHITE1Cleared 510(K)
- K920975BACTIDROP CALCOFLUOR WHITE1Cleared 510(K)
- K920976BACTIDROP INDIA INK1Cleared 510(K)
- K920970BACTIDROP KOH (10%)1Cleared 510(K)
- K893530IRISTAIN FORMULA 2, PARTS 1 AND 21Cleared 510(K)
- K890861ATS DOBELL & O'CONNOR'S IODINE1Cleared 510(K)
- K890020ATS LUGOL'S IODINE SOLUTION1Cleared 510(K)
- K884069SNAP N' STAIN IODINE STAIN1Cleared 510(K)
- K883052METHENO-STAIN KIT1Cleared 510(K)
Show All 40 Submissions
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
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- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ATS DOBELL & O'CONNOR'S IODINE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K890861
- 510(k) Type
- Traditional
- Applicant
- ALPHA-TEC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/23/1989
- Days to Decision
- 30 days