510(k) K850095
- Device
- LASER-DIL
- Applicant
- HEMATOLOGY MARKETING ASSOC.
- 510(k) number
- K850095
- Product code
- GIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-29
- Date received
- 1985-01-11
- Regulation
- 864.8200
- Classification name
- Diluent, Blood Cell
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES LAPICOLA
- Address
- P.O. Box 6756 Concord CA US 94524 94524
FDA Registration Numbers#
- 9610824
- 2432235
- 3004008703
- 3002721051
- 3009711478
- 3016438761
- 3005333358
- 3004016971
- 3005626422
- 3013660430
- 3002806944
- 3009963993
- 1319808
- 3027645317
- 3009297077
- 9610633
- 1177732
- 3002809144
- 3004910133
- 1064608
- 2243072
- 3043088937
- 2221819
- 3000148879
- 3010421384
- 3043138885
- 3011558129
- 1181121
- 3008311438
- 8031673
- 1064130
- 9613959
- 3009156722
- 3010725882
- 3016014873
- 3017237798
- 2020726
- 2013736
- 1419699
- 3004016977
- 3008425728
- 3008629785
- 3010188738
- 1061932
- 3006791549
- 3007603826
- 1034569
- 3005529799
- 1000191380
- 9612316
- 3006949423
- 3008526732
- 1219913
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883990 | KVM ISOTONIC DILUENT | Kvm Technologies, Inc. | 1988-10-12 |
| K883989 | KVM ISOTONIC FLUSH SOLUTION | Kvm Technologies, Inc. | 1988-10-12 |
| K882490 | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT | R&D Systems, Inc. | 1988-07-25 |
| K882267 | SYSMEX QUICKLYSER-II (QLS-200A) | Toa Medical Electronics USA, Inc. | 1988-07-12 |
| K881130 | CELL-DYN ISOTONIC DILUENT | Abbott Diagnostics | 1988-03-31 |
| K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | Abbott Diagnostics | 1987-09-09 |
| K851843 | OSMOCEL 3 | Hematology Marketing Assoc. | 1985-07-30 |
| K851320 | SDI PREPAX DILUKIT M. | Scientific Distributors, Inc. | 1985-07-05 |
| K851280 | DASS PACK | Dass, Inc. | 1985-07-05 |
| K850239 | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- | Toa Medical Electronics USA, Inc. | 1985-04-01 |
| K844782 | NSI ELT-D DILUTING FLUID 4000ML | Nobel Scientific Industries, Inc. | 1985-03-05 |
| K842929 | HAYEM DILUTING FLUID | E K Ind., Inc. | 1984-09-07 |
| K842068 | IDI ISOTONIC DILUENT | Interscience Diagnostics, Inc. | 1984-07-02 |
| K841799 | CYANOMETHEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | 1984-05-31 |
| K840477 | UNITIZED HEMATOLOGY SET 65132/93 | Emd Chemicals, Inc. | 1984-03-05 |
Legacy Summary#
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FDA Review#
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