Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DBTFactor Xiii A, S, Antigen, Antiserum, Control1Product Code
- DDECarbonic Anhydrase C, Antigen, Antiserum, Control1Product Code
- DDFProthrombin, Antigen, Antiserum, Control1Product Code
- DDHCarbonic Anhydrase B, Antigen, Antiserum, Control1Product Code
- DDXPlasminogen, Antigen, Antiserum, Control1Product Code
- K941346PLASMINOGEN RID TEST KIT1Cleared 510(K)
- K884766BERICHROM(R) PLASMINOGEN1Cleared 510(K)
- K864212IL TEST 97573-15, PLASMINOGEN ASSAY1Cleared 510(K)
- K854572COATEST PLASMINOGEN1Cleared 510(K)
- K850410GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY1Cleared 510(K)
- K832591DIACROM *PLG1Cleared 510(K)
- K812625ACA PLASMINOGEN TEST PACK1Cleared 510(K)
- K811777HELENA PLASMINOGEN QUIPLATE PROCEDURE1Cleared 510(K)
- K781478PLASMINOGEN ASSAY1Cleared 510(K)
- K772085LAS-R HUMAN PLASMINOGEN TEST1Cleared 510(K)
- DGBSeminal Fluid, Antigen, Antiserum, Control1Product Code
- DGQWhole Blood Plasma, Antigen, Antiserum, Control1Product Code
- DGRWhole Human Serum, Antigen, Antiserum, Control1Product Code
- KTKReagent, Immunoassay, Carbonic Anhydrase B And C1Product Code
- MVSKit, Typing, Hla-Dqb2Product Code
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
DIACROM *PLG
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K832591
- 510(k) Type
- Traditional
- Applicant
- WELLCOME DIAGNOSTICS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/21/1983
- Days to Decision
- 111 days