510(k) K873348
- Device
- CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
- Applicant
- ABBOTT DIAGNOSTICS
- 510(k) number
- K873348
- Product code
- GGK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-09
- Date received
- 1987-08-20
- Regulation
- 864.8540
- Classification name
- Products, Red-cell Lysing Products
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUTH M BECKER
- Address
- 850 Maude Ave. Mountain View CA US 94043 94043
FDA Registration Numbers#
- 3004008703
- 3002721051
- 3009711478
- 3016438761
- 3012319642
- 3005333358
- 3016764932
- 3005626422
- 3013660430
- 9680746
- 3009297077
- 3013059683
- 3002809144
- 3004450619
- 1064608
- 2221819
- 3000148879
- 3010421384
- 1181121
- 2914537
- 3008311438
- 3003423869
- 1064130
- 9613959
- 3009156722
- 3010725882
- 3008344661
- 3008425728
- 3009189893
- 3008629785
- 8023018
- 3010188738
- 2022180
- 3012494290
- 1017835
- 1061932
- 2122870
- 3027394506
- 3006791549
- 3007603826
- 9610099
- 3005529799
- 1000191380
- 3004107906
- 2050010
- 3006949423
- 3008526732
- 2916205
- 2432235
- 3007496191
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GGK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883836 | COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II | Coulter Immunology | 1988-11-30 |
| K883991 | KVM HEMOGLOBIN LYSING REAGENT | Kvm Technologies, Inc. | 1988-10-12 |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Fisher Scientific Co., LLC | 1987-10-20 |
| K863114 | PIASTRINIT | J. D. Assoc. | 1986-11-06 |
| K863503 | HEMOLYSE | Reagent Laboratory, Inc. | 1986-10-03 |
| K850944 | NSI LYSING-D REAGENT -4000 ML | Nobel Scientific Industries, Inc. | 1985-03-29 |
| K850097 | LASER-LYSE | Hematology Marketing Assoc. | 1985-03-29 |
| K842938 | ACETIC ACID 1% V/V | E K Ind., Inc. | 1984-09-14 |
| K842937 | ACETIC ACID 2% V/V | E K Ind., Inc. | 1984-09-12 |
| K842936 | ACETIC ACID, 3% V/V | E K Ind., Inc. | 1984-09-12 |
| K842935 | ACETIC ACID, 5% V/V | E K Ind., Inc. | 1984-09-12 |
| K842069 | IDL-LYSING REAGENT | Interscience Diagnostics, Inc. | 1984-07-02 |
| K841800 | LYSING & HEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | 1984-05-31 |
| K840289 | LYSE-TEC | Medilab Corp. | 1984-03-05 |
| K834527 | THROMBO PLUS | W. Sarstedt, Inc. | 1984-01-30 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases